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
About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Diabetes
Eligibility Criteria
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
NCT ID
NCT01028846
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)
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
Learn more about this trial
Central Mechanisms That Regulate Glucose Metabolism in Humans
We'll reach out to this number within 24 hrs