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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus
• Interventions: Other: glycogen loading; Other: No Glycogen Loading

• Registration Number: NCT04416204
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Study Start: 2020-08-21
• Primary Completion: 2022-08-15
• Study Completion: 2023-02-15
• Results First Submitted: 2023-09-27
• Results First Submitted QC: 2023-11-29
• Results First Posted: 2023-12-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Participants without diabetes	glycogen loading	Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
Participants without diabetes	No Glycogen Loading	Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
Type 2 diabetes	glycogen loading	Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
Type 2 diabetes	No Glycogen Loading	Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.

Primary Outcome Measures

Name	Time	Method
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes	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 Outcome Measures

Name	Time	Method
Rates of Glycogenolysis in Subjects With Type 2 Diabetes	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	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States