Clinical trial NCT04416204: Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Official title: Role of Hepatic Glycogen on Nocturnal EGP in T2D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
hepatic glycogen
endogenous glucose production
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-06-04
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

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

Primary outcomes:
measure: Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
timeFrame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Secondary outcomes:
measure: Rates of Glycogenolysis in Subjects With Type 2 Diabetes
timeFrame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
measure: Rates of Gluconeogenesis in Healthy Subjects
timeFrame: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: