<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/NCT04416204</url>
  </required_header>
  <id_info>
    <org_study_id>22074</org_study_id>
    <nct_id>NCT04416204</nct_id>
  </id_info>
  <brief_title>Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes</brief_title>
  <official_title>Role of Hepatic Glycogen on Nocturnal EGP in T2D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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 experimental approach in this study intends to investigate the role of hepatic glycogen&#xD;
      content on nocturnal regulation of endogenous glucose production including the relative&#xD;
      contributions of glycogenolysis and gluconeogenesis and the extent to which this differs&#xD;
      between subjects with type 2 diabetes and subjects without diabetes. Both participants with&#xD;
      type 2 diabetes and participants without diabetes will be studied after consuming either a&#xD;
      low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Actual">August 15, 2022</completion_date>
  <primary_completion_date type="Actual">August 15, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The 43 includes subjects that did the dry run NMR scans for optimizing the imaging protocol. There were screen failures not included in this 43.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatic glycogen content and rates of gluconeogenesis in subjects with type 2 diabetes</measure>
    <time_frame>Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks</time_frame>
    <description>1. Hepatic glycogen content will be measured with MRI after either glycogen loading or no glycogen loading meals. We will also measure the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of glycogenolysis in subjects with type 2 diabetes</measure>
    <time_frame>Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks</time_frame>
    <description>1. Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of gluconeogenesis in healthy subjects</measure>
    <time_frame>Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks</time_frame>
    <description>2. Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Type 2 diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants without diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Carbohydrate (glycogen loading)</intervention_name>
    <description>Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.</description>
    <arm_group_label>Participants without diabetes</arm_group_label>
    <arm_group_label>Type 2 diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low carbohydrate (No Glycogen Loading)</intervention_name>
    <description>Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.</description>
    <arm_group_label>Participants without diabetes</arm_group_label>
    <arm_group_label>Type 2 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30-75&#xD;
&#xD;
          -  BMI 20-35kg/m^2&#xD;
&#xD;
          -  Participants with type 2 diabetes:&#xD;
&#xD;
               -  HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with&#xD;
                  metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral&#xD;
                  hypoglycemic agents (Metformin and SU)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Morbidities precluding participation&#xD;
&#xD;
          -  Participants with type 2 diabetes:&#xD;
&#xD;
               -  Therapy with insulin&#xD;
&#xD;
               -  SGLT2 inhibitors&#xD;
&#xD;
               -  GLP-1 based approaches&#xD;
&#xD;
               -  TZDs&#xD;
&#xD;
               -  Unstable diabetic retinopathy&#xD;
&#xD;
               -  Microalbuminuria&#xD;
&#xD;
               -  Macrovascular disease&#xD;
&#xD;
               -  Medications affecting GI motility (eg., erythromycin, pramlintide)&#xD;
&#xD;
               -  Upper GI disorder/surgery&#xD;
&#xD;
          -  Participants without diabetes:&#xD;
&#xD;
               -  Medications (except stable thyroid hormone or hormone replacement therapy) that&#xD;
                  could influence glucose tolerance&#xD;
&#xD;
               -  History of diabetes mellitus in first degree family members or prior history of&#xD;
                  diabetes mellitus or gestational diabetes, or pre-diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Rita Basu, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>hepatic glycogen</keyword>
  <keyword>endogenous glucose production</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 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04416204
org study id: 22074
nct id: NCT04416204
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The experimental approach in this study intends to investigate the role of hepatic glycogen
      content on nocturnal regulation of endogenous glucose production including the relative
      contributions of glycogenolysis and gluconeogenesis and the extent to which this differs
      between subjects with type 2 diabetes and subjects without diabetes. Both participants with
      type 2 diabetes and participants without diabetes will be studied after consuming either a
      low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
masking description: The 43 includes subjects that did the dry run NMR scans for optimizing the imaging protocol. There were screen failures not included in this 43.
measure: Hepatic glycogen content and rates of gluconeogenesis in subjects with type 2 diabetes
time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
description: 1. Hepatic glycogen content will be measured with MRI after either glycogen loading or no glycogen loading meals. We will also measure the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.
measure: Rates of glycogenolysis in subjects with type 2 diabetes
time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
description: 1. Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.
measure: Rates of gluconeogenesis in healthy subjects
time frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
description: 2. Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.
arm group label: Type 2 diabetes
arm group type: Experimental
arm group label: Participants without diabetes
arm group type: Experimental
intervention type: Other
intervention name: High Carbohydrate (glycogen loading)
description: Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
arm group label: Participants without diabetes
arm group label: Type 2 diabetes
intervention type: Other
intervention name: Low carbohydrate (No Glycogen Loading)
description: Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
arm group label: Participants without diabetes
arm group label: Type 2 diabetes
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Rita Basu, MD
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No