Role of Hepatic Glycogen on Nocturnal EGP in T2D
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
A total of 34 subjects participated.
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
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
- 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 of Gluconeogenesis in Healthy Subjects(Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks)
Investigators
Rita Basu
Principal Investigator
University of Alabama at Birmingham