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Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Carbohydrate (glycogen loading)
Low carbohydrate (No Glycogen Loading)
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, hepatic glycogen, endogenous glucose production

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 30-75
  • BMI 20-35kg/m^2

  • Participants with type 2 diabetes:

    • HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Morbidities precluding participation

  • Participants with type 2 diabetes:

    • Therapy with insulin
    • SGLT2 inhibitors
    • GLP-1 based approaches
    • TZDs
    • Unstable diabetic retinopathy
    • Microalbuminuria
    • Macrovascular disease
    • Medications affecting GI motility (eg., erythromycin, pramlintide)
    • Upper GI disorder/surgery

  • Participants without diabetes:

    • Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
    • History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Type 2 diabetes

Participants without diabetes

Arm Description

Outcomes

Primary Outcome Measures

Hepatic glycogen content and rates of gluconeogenesis in subjects with type 2 diabetes
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.

Secondary Outcome Measures

Rates of glycogenolysis in subjects with type 2 diabetes
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.
Rates of gluconeogenesis in healthy subjects
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.

Full Information

First Posted
June 1, 2020
Last Updated
September 22, 2023
Sponsor
University of Virginia
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04416204
Brief Title
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Official Title
Role of Hepatic Glycogen on Nocturnal EGP in T2D
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, hepatic glycogen, endogenous glucose production

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 diabetes
Arm Type
Experimental
Arm Title
Participants without diabetes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High Carbohydrate (glycogen loading)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Low carbohydrate (No Glycogen Loading)
Intervention 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.
Primary Outcome Measure Information:
Title
Hepatic glycogen content and rates of gluconeogenesis in subjects with type 2 diabetes
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.
Time Frame
Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Secondary Outcome Measure Information:
Title
Rates of glycogenolysis in subjects with type 2 diabetes
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.
Time Frame
Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Title
Rates of gluconeogenesis in healthy subjects
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.
Time Frame
Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 30-75 BMI 20-35kg/m^2 Participants with type 2 diabetes: HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU) Exclusion Criteria: Pregnancy or breast feeding Morbidities precluding participation Participants with type 2 diabetes: Therapy with insulin SGLT2 inhibitors GLP-1 based approaches TZDs Unstable diabetic retinopathy Microalbuminuria Macrovascular disease Medications affecting GI motility (eg., erythromycin, pramlintide) Upper GI disorder/surgery Participants without diabetes: Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes

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