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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Role of Hepatic Glycogen on Nocturnal EGP in T2D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416204
• Other study ID #: 22074
• Secondary ID: R01DK029953
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 15, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes	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.	Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Secondary	Rates of Glycogenolysis in Subjects With Type 2 Diabetes	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.	Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Secondary	Rates of Gluconeogenesis in Healthy Subjects	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.	Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks