N/A
Completed N=29
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Source: ClinicalTrials.gov NCT04416204 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes — 8.2; 9.4; 17.4; 15.6 umol/kgFFM/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes |
8.2; 9.4; 17.4; 15.6 | — |
| SECONDARY Rates of Glycogenolysis in Subjects With Type 2 Diabetes |
9.2; 6.3; 17.4; 15.6 | — |
| SECONDARY Rates of Gluconeogenesis in Healthy Subjects |
7.7; 8.5; 15.9; 13.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04416204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.