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

University of Alabama at Birmingham34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2

Interventions

glycogen loadingOTHER

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

No Glycogen LoadingOTHER

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Rates of Glycogenolysis in Subjects With Type 2 Diabetes

Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.

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

Rates of Gluconeogenesis in Healthy Subjects

Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.

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

Data from ClinicalTrials.gov

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