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Central Mechanisms That Regulate Glucose Metabolism in Humans

Primary Purpose

Type 2 Diabetes, Glucose Metabolism Disorders, Glucose, High Blood

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diazoxide
Placebo
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Diabetes

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diazoxide

Placebo

Arm Description

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

Intravenous normal saline during pancreatic clamp study

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 7, 2009
Last Updated
November 11, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01028846
Brief Title
Central Mechanisms That Regulate Glucose Metabolism in Humans
Official Title
Central Mechanisms That Regulate Glucose Metabolism in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Glucose Metabolism Disorders, Glucose, High Blood
Keywords
Type 2 Diabetes, Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diazoxide
Arm Type
Active Comparator
Arm Description
1-2 mg/kg total dose given intravenously during pancreatic clamp study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline during pancreatic clamp study
Intervention Type
Drug
Intervention Name(s)
Diazoxide
Other Intervention Name(s)
Proglycem
Intervention Description
1-2 mg/kg total dose given intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous normal saline
Primary Outcome Measure Information:
Title
Endogenous Glucose Production (EGP)
Description
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).
Time Frame
Final 60 minutes (t=180-240 minutes) of the pancreatic clamp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Hyperlipidemia Hypertension Heart disease Cerebrovascular disease Seizures Bleeding disorders Muscle disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith Hawkins, M.D., M.S.
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

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Central Mechanisms That Regulate Glucose Metabolism in Humans

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