RecruitingPhase 2NCT03540758

Regulation of Endogenous Glucose Production by Central KATP Channels

Sponsor

Albert Einstein College of Medicine

Enrollment

100 participants

Start Date

Aug 1, 2018

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Glucose Metabolism Disorders

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how special channels in the brain (called KATP channels) help regulate blood sugar levels, and whether they work differently in people with type 2 diabetes compared to healthy individuals. **You may be eligible if...** - You are between 21 and 70 years old - Your BMI is under 35 - You have type 2 diabetes with moderate-to-poor blood sugar control (HbA1c between 8.0% and 12.0%), OR you are a healthy non-diabetic person with no family history of diabetes - Your drug screen is negative **You may NOT be eligible if...** - You are under 21 or over 70 years old - Your BMI is 35 or higher - You have severely high blood pressure or very low blood pressure on more than one occasion - You have serious diabetes complications such as severe proliferative eye disease, significant kidney disease, or severe nerve damage - You have severe thirst and urination symptoms - Your cholesterol or triglyceride levels are dangerously high - You have significant liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDiazoxide

Non-diabetic participants will receive diazoxide at a dose of 4-7 mg/kg (based upon weight) during the pancreatic clamp study.

DRUGNicotinic acid

Non-diabetic participants will receive nicotinic acid infusion based on weight (0.01 mg/kg/min) during the pancreatic clamp study.

DRUGPlacebo

Non-diabetic participants will receive placebo and undergo the pancreatic clamp study. T2D participants will have their blood sugar levels normalized, and will then receive a taste-matched placebo for diazoxide before undergoing the pancreatic clamp study.

Locations(1)

Albert Einstein College of Medicine

The Bronx, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03540758

Related Trials

Genetic Studies of Insulin and Diabetes

NCT000019871 location

A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection

NCT074894821 location