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

NCT04416204 | Completed Results

• 2 other identifiers: 22074R01DK029953
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; hepatic glycogen; endogenous glucose production

Outcome Measures

Primary Outcomes (1)

• Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes

  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.

  Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Type 2 diabetes

EXPERIMENTAL

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

Other: glycogen loading; Other: No Glycogen Loading

Participants without diabetes

EXPERIMENTAL

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

Other: glycogen loading; Other: No Glycogen Loading

Interventions

glycogen loading OTHER

Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.

Participants without diabetes; Type 2 diabetes

No Glycogen Loading OTHER

Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.

Participants without diabetes; Type 2 diabetes

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Mayo Clinic: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

• Though unlikely, it is possible that additional steps to load hepatic glycogen maybe necessary (e.g., late night snack: high carb in GL and isocaloric low carb in NGL) to maximize differences in liver glycogen contents between visits.

Results Point of Contact

• Title: Dr. Rita Basu
• Organization: University of Alabama at Birmingham

rbasu@uabmc.edu

2059341200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A total of 34 subjects participated.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: August 21, 2020
• Primary Completion: August 15, 2022
• Study Completion: February 15, 2023
• Last Updated: March 1, 2024
• Results First Posted: December 18, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)