N/A N=29 Randomized Basic Science

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

Diabetes Mellitus · Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT04416204 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes — 8.2; 9.4; 17.4; 15.6 umol/kgFFM/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: glycogen loading (Other); No Glycogen Loading (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Aug 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.