<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/NCT03793855</url>
  </required_header>
  <id_info>
    <org_study_id>NUGLIC</org_study_id>
    <nct_id>NCT03793855</nct_id>
  </id_info>
  <brief_title>Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)</brief_title>
  <official_title>Effectiveness of a Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus Users of a Public Health System: NUGLIC Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital do Coracao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital do Coracao</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>
      Adherence to a healthy dietary pattern is part of the self-care of patients with type 2&#xD;
      diabetes mellitus (T2DM), and may contribute substantially to therapeutic target goals and to&#xD;
      a better quality of life as well. However, not all nutritional recommendations aimed at these&#xD;
      patients are easily applicable in clinical practice. The primary objective of the study is to&#xD;
      evaluate the effectiveness of a nutritional strategy for glycemic control in patients with&#xD;
      T2DM users of a Public Health System after 6 months of follow-up. As secondary objectives, we&#xD;
      will evaluate the impact of the proposed strategy on self-care and on the quality of life of&#xD;
      the patients. In this randomized multicenter open-label randomized trial, 370 patients &gt;30&#xD;
      years old with T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who&#xD;
      have not received or received nutritional counseling for at least 06 months will be enrolled.&#xD;
      Patients allocated to the control group will receive individualized dietary prescription&#xD;
      according to the guidelines of the Brazilian Society of Diabetes. Nutritional counseling in&#xD;
      the intervention group will be performed based on the quality of the diet, the Food Guide for&#xD;
      the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance&#xD;
      will be based on feasible goals built together (patient and nutritionist), and no diet will&#xD;
      be prescribed for intervention group. In both groups, patients will receive glymeters for&#xD;
      residential self-monitoring of glycemic levels. On-site follow-up visits will be carried out&#xD;
      at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the&#xD;
      intervention group will receive motivational messages via e-mail or SMS (for these patients,&#xD;
      consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic&#xD;
      profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium&#xD;
      and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and blood&#xD;
      pressure will be also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 28, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1C</measure>
    <time_frame>6 months</time_frame>
    <description>Glycated hemoglobin, in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GC</measure>
    <time_frame>6 months</time_frame>
    <description>Glycemic control, defined as either having HbA1C &gt; 7% at baseline and achieving HbA1C ≤ 7% after follow-up or having HbA1C &lt; 7% at baseline and reducing anti-diabetic drugs after follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FG</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting glucose, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SBP</measure>
    <time_frame>6 months</time_frame>
    <description>Systolic blood pressure, in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBP</measure>
    <time_frame>6 months</time_frame>
    <description>Diastolic blood pressure, in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>HDL cholesterol, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TC</measure>
    <time_frame>6 months</time_frame>
    <description>Total cholesterol, in md/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG</measure>
    <time_frame>6 months</time_frame>
    <description>Serum triglycerides, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Castelli Index I</measure>
    <time_frame>6 months</time_frame>
    <description>Castelli Index I, obtained by the mathematical formula TC/HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VLDL-c</measure>
    <time_frame>6 months</time_frame>
    <description>VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NHDL</measure>
    <time_frame>6 months</time_frame>
    <description>Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Castelli Index II</measure>
    <time_frame>6 months</time_frame>
    <description>Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BW</measure>
    <time_frame>6 months</time_frame>
    <description>Body weight, in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WC</measure>
    <time_frame>6 months</time_frame>
    <description>Waist circumference, in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>6 months</time_frame>
    <description>Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cr</measure>
    <time_frame>6 months</time_frame>
    <description>Creatinine, in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GFR</measure>
    <time_frame>6 months</time_frame>
    <description>Glomerular filtration rate, in ml/min/1.73m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium (s)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum sodium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium (u)</measure>
    <time_frame>6 months</time_frame>
    <description>Urinary sodium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium (s)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum potassium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium (u)</measure>
    <time_frame>6 months</time_frame>
    <description>Urinary potassium, in mEq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALB</measure>
    <time_frame>6 months</time_frame>
    <description>Albuminuria, in mg/g</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-PAID</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale. The scale consists of 20 questions; it uses a score from 0 to 100, in which the maximum score is configured as greater suffering. The possible response options are divided on a 5-point Likert scale, ranging from: &quot;Not a problem=0&quot;, &quot;Small problem=1&quot;, &quot;Moderate problem=2&quot;, &quot;Almost serious problem=3&quot;, &quot;Serious problem=4&quot;. A cut-off point equal or greater 40 indicates a high degree of emotional distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSCA</measure>
    <time_frame>6 months</time_frame>
    <description>Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities. The questionnaire has six domains and 15 items for assessment of the diabetes self-care; it is based on the number of days per week in which the respondent has a given behavior, with each item scoring from 0 to 7 points (i.e. 0 is the least desirable situation and 7 is the most desirable one). At least five days for each self-care activity is considered adequate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DQ</measure>
    <time_frame>6 months</time_frame>
    <description>Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>TT</measure>
    <time_frame>6 months</time_frame>
    <description>Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP &lt; 130/80 mmHg; HbA1C &lt;7%; LDL-c &lt;100 mg/dL; BMI &lt; 25 kg/m2 or weight loss &gt; 7%</description>
  </other_outcome>
  <other_outcome>
    <measure>ADD</measure>
    <time_frame>6 months</time_frame>
    <description>Anti-diabetic drugs, defined as the type and proportion of anti-diabetic drugs used</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Nutritional Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Prescription</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Strategy</intervention_name>
    <description>Counseling based on dietary goals and mindfulness techniques.</description>
    <arm_group_label>Nutritional Strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Prescription</intervention_name>
    <description>Dietary prescription according to guidelines.</description>
    <arm_group_label>Dietary Prescription</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: &gt;30 years old with medical diagnosis of T2DM, glycated hemoglobin&#xD;
        (HbA1C) ≥7% at the moment of the screening and who have not received or received&#xD;
        nutritional counseling for at least 06 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type 1 DM (T1DM), latent autoimmune diabetes in adults (LADA) or HbA1C ≥&#xD;
             12%;&#xD;
&#xD;
          -  Severe neuropathy;&#xD;
&#xD;
          -  Chronic kidney disease;&#xD;
&#xD;
          -  Active cancer or life expectancy &lt;6 months;&#xD;
&#xD;
          -  Chemical dependence or use of antipsychotic drugs;&#xD;
&#xD;
          -  Autoimmune disease or chronic use of steroids;&#xD;
&#xD;
          -  Gastroparesis;&#xD;
&#xD;
          -  Pregnancy, lactation, gestational DM;&#xD;
&#xD;
          -  Acute coronary syndrome (ACS) in the last 60 days;&#xD;
&#xD;
          -  Wheelchair users;&#xD;
&#xD;
          -  Extreme obesity (body mass index [BMI] ≥40kg/m²);&#xD;
&#xD;
          -  Cognitive, neurological or psychiatric condition that prevents participation in the&#xD;
             study;&#xD;
&#xD;
          -  Participation in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aline Marcadenti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital do Coracao</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Juiz de Fora</name>
      <address>
        <city>Governador Valadares</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Lavras</name>
      <address>
        <city>Lavras</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Ciências da Saúde de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Estadual de Cardiologia Aloysio de Castro</name>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal da Bahia</name>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Coracao</name>
      <address>
        <city>São Paulo</city>
        <zip>04004-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Viçosa</name>
      <address>
        <city>Viçosa</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.</ipd_description>
    <ipd_time_frame>Data will be available after main paper publication.</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT03793855
org study id: NUGLIC
nct id: NCT03793855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adherence to a healthy dietary pattern is part of the self-care of patients with type 2
      diabetes mellitus (T2DM), and may contribute substantially to therapeutic target goals and to
      a better quality of life as well. However, not all nutritional recommendations aimed at these
      patients are easily applicable in clinical practice. The primary objective of the study is to
      evaluate the effectiveness of a nutritional strategy for glycemic control in patients with
      T2DM users of a Public Health System after 6 months of follow-up. As secondary objectives, we
      will evaluate the impact of the proposed strategy on self-care and on the quality of life of
      the patients. In this randomized multicenter open-label randomized trial, 370 patients >30
      years old with T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who
      have not received or received nutritional counseling for at least 06 months will be enrolled.
      Patients allocated to the control group will receive individualized dietary prescription
      according to the guidelines of the Brazilian Society of Diabetes. Nutritional counseling in
      the intervention group will be performed based on the quality of the diet, the Food Guide for
      the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance
      will be based on feasible goals built together (patient and nutritionist), and no diet will
      be prescribed for intervention group. In both groups, patients will receive glymeters for
      residential self-monitoring of glycemic levels. On-site follow-up visits will be carried out
      at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the
      intervention group will receive motivational messages via e-mail or SMS (for these patients,
      consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic
      profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium
      and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and blood
      pressure will be also evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: HbA1C
time frame: 6 months
description: Glycated hemoglobin, in %
measure: GC
time frame: 6 months
description: Glycemic control, defined as either having HbA1C > 7% at baseline and achieving HbA1C ≤ 7% after follow-up or having HbA1C < 7% at baseline and reducing anti-diabetic drugs after follow-up.
measure: FG
time frame: 6 months
description: Fasting glucose, in mg/dL
measure: SBP
time frame: 6 months
description: Systolic blood pressure, in mmHg
measure: DBP
time frame: 6 months
description: Diastolic blood pressure, in mmHg
measure: HDL-c
time frame: 6 months
description: HDL cholesterol, in mg/dL
measure: LDL-c
time frame: 6 months
description: LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula
measure: TC
time frame: 6 months
description: Total cholesterol, in md/dL
measure: TG
time frame: 6 months
description: Serum triglycerides, in mg/dL
measure: Castelli Index I
time frame: 6 months
description: Castelli Index I, obtained by the mathematical formula TC/HDL-c
measure: VLDL-c
time frame: 6 months
description: VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5
measure: NHDL
time frame: 6 months
description: Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c
measure: Castelli Index II
time frame: 6 months
description: Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c
measure: BW
time frame: 6 months
description: Body weight, in kg
measure: WC
time frame: 6 months
description: Waist circumference, in cm
measure: BMI
time frame: 6 months
description: Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)
measure: Cr
time frame: 6 months
description: Creatinine, in mg/dL
measure: GFR
time frame: 6 months
description: Glomerular filtration rate, in ml/min/1.73m2
measure: Sodium (s)
time frame: 6 months
description: Serum sodium, in mEq/L
measure: Sodium (u)
time frame: 6 months
description: Urinary sodium, in mEq/L
measure: Potassium (s)
time frame: 6 months
description: Serum potassium, in mEq/L
measure: Potassium (u)
time frame: 6 months
description: Urinary potassium, in mEq/L
measure: ALB
time frame: 6 months
description: Albuminuria, in mg/g
measure: B-PAID
time frame: 6 months
description: Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale. The scale consists of 20 questions; it uses a score from 0 to 100, in which the maximum score is configured as greater suffering. The possible response options are divided on a 5-point Likert scale, ranging from: "Not a problem=0", "Small problem=1", "Moderate problem=2", "Almost serious problem=3", "Serious problem=4". A cut-off point equal or greater 40 indicates a high degree of emotional distress.
measure: DSCA
time frame: 6 months
description: Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities. The questionnaire has six domains and 15 items for assessment of the diabetes self-care; it is based on the number of days per week in which the respondent has a given behavior, with each item scoring from 0 to 7 points (i.e. 0 is the least desirable situation and 7 is the most desirable one). At least five days for each self-care activity is considered adequate.
measure: DQ
time frame: 6 months
description: Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)
measure: TT
time frame: 6 months
description: Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP < 130/80 mmHg; HbA1C <7%; LDL-c <100 mg/dL; BMI < 25 kg/m2 or weight loss > 7%
measure: ADD
time frame: 6 months
description: Anti-diabetic drugs, defined as the type and proportion of anti-diabetic drugs used
arm group label: Nutritional Strategy
arm group type: Experimental
description: Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).
arm group label: Dietary Prescription
arm group type: Active Comparator
description: Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.
intervention type: Behavioral
intervention name: Nutritional Strategy
description: Counseling based on dietary goals and mindfulness techniques.
arm group label: Nutritional Strategy
intervention type: Behavioral
intervention name: Dietary Prescription
description: Dietary prescription according to guidelines.
arm group label: Dietary Prescription
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Aline Marcadenti, PhD
role: Principal Investigator
affiliation: Hospital do Coracao
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
ipd time frame: Data will be available after main paper publication.