Central Mechanisms That Regulate Glucose Metabolism in Humans

Albert Einstein College of Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Glucose Metabolism Disorders; Type 2 Diabetes; Glucose, High Blood

Treatments: Drug: Diazoxide; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01028846

2006-414

R01DK069861 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to coordinate this process by communicating with the liver through potassium channels. Control of EGP can be impaired in people with type 2 diabetes, which may contribute to the high levels of glucose seen in these individuals.

The purpose of this study is to understand how activating these potassium channels in the control centers of the brain with a medication called diazoxide might inhibit the amount of glucose made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn causes hyperglycemia (high levels of sugar in the blood) that leads to diabetes complications.

Full description

In this study, the investigators will study healthy participants through a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (the production of sugar by the liver) will be measured in patients given diazoxide (a medication that activates potassium channels in the brain that may affect glucose production in the liver through brain-liver signaling), compared with when a placebo is given.

Enrollment: 10 estimated patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• Hyperlipidemia
• Hypertension
• Heart disease
• Cerebrovascular disease
• Seizures
• Bleeding disorders
• Muscle disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Diazoxide

Active Comparator group

Description:

1-2 mg/kg total dose given intravenously during pancreatic clamp study

Treatment:

Drug: Diazoxide

Placebo

Placebo Comparator group

Description:

Intravenous normal saline during pancreatic clamp study

Treatment:

Drug: Placebo