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

Overview

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.

Full Title of Study: “Role of Hepatic Glycogen on Nocturnal EGP in T2D”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 15, 2022

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.

Interventions

  • Other: glycogen loading
    • Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
  • Other: No Glycogen Loading
    • Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.

Arms, Groups and Cohorts

  • Experimental: Type 2 diabetes
    • Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
  • Experimental: Participants without diabetes
    • Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • We measured 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 Measures

  • 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
    • 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
    • Time Frame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rita Basu, Principal Investigator – University of Alabama at Birmingham

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