Regulation of Endogenous Glucose Production by Central KATP Channels

NCT03540758 Phase 2 RECRUITING

Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.

Details

Lead sponsor	Albert Einstein College of Medicine
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2018-08-01
Completion	2027-04

Conditions

• Diabetes Mellitus
• Glucose Metabolism Disorders

Interventions

• Diazoxide
• Nicotinic acid
• Placebo

Primary outcomes

• Change in Endogenous glucose production (EGP) rate — 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration
  Rates of EGP (a measure of the body's production of sugar) will be measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., placebo, diazoxide, nicotinic acid, nicotinic acid/diazoxide), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Measurement of blood glucose concentrations will either be performed with a Precision Xceed Pro glucometer or an Analox glucose analyzer in the study room. Increased EGP is the major cause of fasting hyperglycemia. EGP will be determined by subtracting the rates of glucose infusion from the tracer-derived Rates of glucose appearance (Ra). Rates of change in EGP will be reported in concentration/time and summarized by study arm using basic descriptive statistics.

Countries

United States