<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761186</url>
  </required_header>
  <id_info>
    <org_study_id>2018/218-31</org_study_id>
    <nct_id>NCT03761186</nct_id>
  </id_info>
  <brief_title>Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes</brief_title>
  <acronym>DANCE</acronym>
  <official_title>DANCE (Diabetes ANd CarbohydratEs). Does the Amount of Dietary Carbohydrates Affect Insulin Requirements and Metabolic Control in Type 1 Diabetes? Comparative Study of Traditional Diabetes, Moderately Low and Strictly Low Carbohydrate Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anneli Björklund</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with&#xD;
      the current recommendations being based on type 2 diabetes studies. Therefore the overall&#xD;
      purpose of this study is to improve the current evidence for dietary recommendations to&#xD;
      people with type 1 diabetes.&#xD;
&#xD;
      Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate&#xD;
      diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin&#xD;
      requirements and metabolic control in individuals with type 1 diabetes.&#xD;
&#xD;
      Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet,&#xD;
      30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate&#xD;
      diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day&#xD;
      is usually called very low carbohydrate diet or ketogenic and will not be tested in this&#xD;
      study.&#xD;
&#xD;
      Those who wish to participate and meet the inclusion criteria (and none of the exclusion&#xD;
      criteria) will be randomized to one of the three diets. The duration of the intervention is 6&#xD;
      months after which the participants will be able to choose their own diet for another 6&#xD;
      months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12&#xD;
      months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study&#xD;
      nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the&#xD;
      start of the intervention in order to be able to match their insulin to the amount&#xD;
      carbohydrates they eat. Participants will receive written materials about their diets with&#xD;
      menus and recipes for better adherence to the diet.&#xD;
&#xD;
      The primary endpoint is the change in insulin requirements within and between groups (for&#xD;
      secondary endpoints please see relevant section). For assessing the different endpoints the&#xD;
      participants will provide blood, urine and feces samples for lab analyses as well as register&#xD;
      their insulin use, blood glucose, diet, physical activity and any blood ketones or&#xD;
      hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring&#xD;
      (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food&#xD;
      diaries before every scheduled study visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Nurses that will take lab samples as well as laboratory personal that analyses the samples will be masked. Due to the nature of the study, it is not possible to mask the participants or the care providers/investigators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in insulin use</measure>
    <time_frame>screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>measured in international units (IU) and percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/mol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of total cholesterol</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of triglycerides</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of HDL-cholesterol</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of LDL-cholesterol</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of LDL/HDL</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>absolute number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of glucagon</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>pmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal circumference</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of p-creatinine</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>micromol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mL/min/1,73 m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microalbuminuria</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>morning U-Alb/Crea (mg/mmol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Insulin-like Growth Factor 1 (IGF-I)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>microg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>microg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of leptin</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>microg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of adiponectin</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of interleukin 6 (IL-6)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>ng/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of high sensitivity c-Reactive Protein (Hs-CRP)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>measured in endotoxin units (EU)/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of glutaredoxin 1 (GRX-1)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Oxidized LDL</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Antioxidant Capacity (TAC)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of reactive oxygen species (ROS)</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics</measure>
    <time_frame>screening, 3 months, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score from the Short Form 36 (SF-36) questionnaire</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score from the Well-being Questionnaire-12 (WBQ-12)</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The negative well-being scale score (range 0-12) is reversed and then summed with the Energy score (range 0-12) and Positive score (range 0-12) to produce a general well-being score (range 0-36). The higher the score the greater the sense of general well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The ﬁrst factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the ﬁrst factor (total score 36), with a higher score indicating higher treatment satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to complete the Trail making test A+B</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric, measured in seconds and or minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Carbohydrate intake</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>in grams/day</description>
  </other_outcome>
  <other_outcome>
    <measure>Energy intake from carbohydrates</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>% of total energy intake</description>
  </other_outcome>
  <other_outcome>
    <measure>Daily energy intake of participants</measure>
    <time_frame>screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>kcal/day</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ)</measure>
    <time_frame>screening, 6 months,12 months</time_frame>
    <description>The participants will fill in how frequent they consume 132 different food items. The available frequency responses are: 0/month, 1-3/month, 1-2/week, 3-4/week, 5-6/week, 1/day, 2/day, 3+/day.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>traditional diabetes diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderately low carbohydrate diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>strictly low carbohydrate diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>traditional diabetes diet</intervention_name>
    <description>Diet with carbohydrate content 50-60% of total energy intake</description>
    <arm_group_label>traditional diabetes diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>moderately low carbohydrate diet</intervention_name>
    <description>Diet with carbohydrate content 30-40% of total energy intake</description>
    <arm_group_label>moderately low carbohydrate diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>strictly low carbohydrate diet</intervention_name>
    <description>Diet with carbohydrate content 15-20% of total energy intake</description>
    <arm_group_label>strictly low carbohydrate diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have had type 1 diabetes for at least 1 year&#xD;
&#xD;
          -  Age &gt;=20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular disease NYHA class IIIB or more&#xD;
&#xD;
          -  Kidney disease &gt; stadium 3&#xD;
&#xD;
          -  Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,&#xD;
&#xD;
          -  BMI &lt; 18.5 kg/m^2&#xD;
&#xD;
          -  c-peptide ≥ 0.3 nmol/l&#xD;
&#xD;
          -  Pregnant/breastfeeding women, women that plan to get pregnant during study period&#xD;
&#xD;
          -  Other circumstances, which, according to the examiner, make it difficult for an&#xD;
             individual to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anneli Björklund, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anneli Björklund, MD, PhD</last_name>
    <phone>070 5269791</phone>
    <phone_ext>+46</phone_ext>
    <email>anneli.bjorklund@ki.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Afroditi Barouti, MSc</last_name>
    <phone>0812367162</phone>
    <phone_ext>+46</phone_ext>
    <email>afroditi.barouti@ki.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center for Diabetes, Academic Specialistcenter</name>
      <address>
        <city>Stockholm</city>
        <zip>11365</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anneli Björklund, MD</last_name>
      <email>anneli.bjorklund@ki.se</email>
    </contact>
    <investigator>
      <last_name>Anneli Björklund, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 23, 2022</last_update_submitted>
  <last_update_submitted_qc>October 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anneli Björklund</investigator_full_name>
    <investigator_title>Principal Investigator, Senior Consultant, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>low carbohydrate diet</keyword>
  <keyword>randomized trial</keyword>
  <keyword>adults</keyword>
  <keyword>insulin</keyword>
  <keyword>metabolic control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761186
org study id: 2018/218-31
nct id: NCT03761186
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with
      the current recommendations being based on type 2 diabetes studies. Therefore the overall
      purpose of this study is to improve the current evidence for dietary recommendations to
      people with type 1 diabetes.

      Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate
      diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin
      requirements and metabolic control in individuals with type 1 diabetes.

      Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet,
      30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate
      diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day
      is usually called very low carbohydrate diet or ketogenic and will not be tested in this
      study.

      Those who wish to participate and meet the inclusion criteria (and none of the exclusion
      criteria) will be randomized to one of the three diets. The duration of the intervention is 6
      months after which the participants will be able to choose their own diet for another 6
      months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12
      months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study
      nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the
      start of the intervention in order to be able to match their insulin to the amount
      carbohydrates they eat. Participants will receive written materials about their diets with
      menus and recipes for better adherence to the diet.

      The primary endpoint is the change in insulin requirements within and between groups (for
      secondary endpoints please see relevant section). For assessing the different endpoints the
      participants will provide blood, urine and feces samples for lab analyses as well as register
      their insulin use, blood glucose, diet, physical activity and any blood ketones or
      hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring
      (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food
      diaries before every scheduled study visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Nurses that will take lab samples as well as laboratory personal that analyses the samples will be masked. Due to the nature of the study, it is not possible to mask the participants or the care providers/investigators.
measure: Change in insulin use
time frame: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: measured in international units (IU) and percentage.
measure: Change in HbA1c
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: mmol/mol
measure: Change in concentration of total cholesterol
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mmol/L
measure: Change in concentration of triglycerides
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mmol/L
measure: Change in concentration of HDL-cholesterol
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mmol/L
measure: Change in concentration of LDL-cholesterol
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mmol/L
measure: Ratio of LDL/HDL
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: absolute number
measure: Concentration of glucagon
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: pmol/L
measure: Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mmol/L
measure: Change in weight
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: kg
measure: Change in BMI
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: kg/m^2
measure: Change in abdominal circumference
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: cm
measure: Change in concentration of p-creatinine
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: micromol/L
measure: Change in estimated Glomerular Filtration Rate (eGFR)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mL/min/1,73 m2
measure: Change in microalbuminuria
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: morning U-Alb/Crea (mg/mmol)
measure: Concentration of Insulin-like Growth Factor 1 (IGF-I)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: microg/L
measure: Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: microg/L
measure: Concentration of leptin
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: microg/L
measure: Concentration of adiponectin
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mg/L
measure: Concentration of interleukin 6 (IL-6)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: ng/L
measure: Concentration of high sensitivity c-Reactive Protein (Hs-CRP)
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: mg/L
measure: Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay
time frame: screening, 3 months, 6 months, 9 months, 12 months
description: measured in endotoxin units (EU)/ml
measure: Concentration of glutaredoxin 1 (GRX-1)
time frame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of Oxidized LDL
time frame: screening, 3 months, 6 months, 9 months, 12 months
measure: Total Antioxidant Capacity (TAC)
time frame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of reactive oxygen species (ROS)
time frame: screening, 3 months, 6 months, 9 months, 12 months
measure: Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics
time frame: screening, 3 months, 6 months, 9 months, 12 months
measure: Score from the Short Form 36 (SF-36) questionnaire
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Score from the Well-being Questionnaire-12 (WBQ-12)
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The negative well-being scale score (range 0-12) is reversed and then summed with the Energy score (range 0-12) and Positive score (range 0-12) to produce a general well-being score (range 0-36). The higher the score the greater the sense of general well-being.
measure: Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The ﬁrst factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the ﬁrst factor (total score 36), with a higher score indicating higher treatment satisfaction.
measure: Time taken to complete the Trail making test A+B
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric, measured in seconds and or minutes.
measure: Carbohydrate intake
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: in grams/day
measure: Energy intake from carbohydrates
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: % of total energy intake
measure: Daily energy intake of participants
time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
description: kcal/day
measure: Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ)
time frame: screening, 6 months,12 months
description: The participants will fill in how frequent they consume 132 different food items. The available frequency responses are: 0/month, 1-3/month, 1-2/week, 3-4/week, 5-6/week, 1/day, 2/day, 3+/day.
arm group label: traditional diabetes diet
arm group type: Active Comparator
description: Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake
arm group label: moderately low carbohydrate diet
arm group type: Experimental
description: Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake
arm group label: strictly low carbohydrate diet
arm group type: Experimental
description: Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake
intervention type: Behavioral
intervention name: traditional diabetes diet
description: Diet with carbohydrate content 50-60% of total energy intake
arm group label: traditional diabetes diet
intervention type: Behavioral
intervention name: moderately low carbohydrate diet
description: Diet with carbohydrate content 30-40% of total energy intake
arm group label: moderately low carbohydrate diet
intervention type: Behavioral
intervention name: strictly low carbohydrate diet
description: Diet with carbohydrate content 15-20% of total energy intake
arm group label: strictly low carbohydrate diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Anneli Björklund, MD, PhD
role: Principal Investigator
affiliation: Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum
last name: Anneli Björklund, MD, PhD
phone: 070 5269791
phone ext: +46
email: anneli.bjorklund@ki.se
last name: Afroditi Barouti, MSc
phone: 0812367162
phone ext: +46
email: afroditi.barouti@ki.se
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anneli Björklund
investigator title: Principal Investigator, Senior Consultant, Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1