Status:
COMPLETED
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
NA
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 gly...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04416204
Start Date
August 21 2020
End Date
February 15 2023
Last Update
March 1 2024
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908