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

The University of Alabama at Birmingham

Status: Completed

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Other: No Glycogen Loading; Other: glycogen loading

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04416204

R01DK029953 (U.S. NIH Grant/Contract)

22074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Type 2 diabetes

Experimental group

Description:

Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.

Treatment:

Other: glycogen loading

Other: No Glycogen Loading

Participants without diabetes

Experimental group

Description:

Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.

Treatment:

Other: glycogen loading

Other: No Glycogen Loading