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Completed

NCT Number: NCT04416204

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

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.

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glycogen loading

Other

Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.

No Glycogen Loading

Other

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Mayo Clinic
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Role of Hepatic Glycogen on Nocturnal EGP in T2D

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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