Central Mechanisms That Regulate Glucose Metabolism in Humans

Type 2 Diabetes Clinical Trial

Official title:

Central Mechanisms That Regulate Glucose Metabolism in Humans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01028846
• Other study ID #: 2006-414
• Secondary ID: R01DK069861
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Hyperlipidemia

• Hypertension

• Heart disease

• Cerebrovascular disease

• Seizures

• Bleeding disorders

• Muscle disease

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Glucose, High Blood
• Metabolic Diseases
• Type 2 Diabetes

Intervention

Drug:
• Diazoxide
1-2 mg/kg total dose given intravenously
• Placebo
Intravenous normal saline

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous Glucose Production (EGP)	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 (eg, diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).	Final 60 minutes (t=180-240 minutes) of the pancreatic clamp