Regulation of Endogenous Glucose Production by Central KATP Channels

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: t
View:

⁃ For healthy participants:

• Age: 21-70 years old

• Body Mass Index (BMI) under 35

• Negative drug screen

• Normal Hemoglobin A1c (HbA1c) and fasting glucose

• No family history of diabetes among first degree relatives (e.g., mother, father)

⁃ For T2D participants:

• Age: 21-70 years old

• BMI under 35

• Stable and moderate-to-poor glycemic control (HbA1c: 8.0-12.0%)

• Negative drug screen

• Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction).

Locations
United States
New York
Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Meredith Hawkins, M.D., M.S.
meredith.hawkins@einsteinmed.edu
718-430-2903
Time Frame
Start Date: 2018-08-01
Estimated Completion Date: 2027-04
Participants
Target number of participants: 100
Treatments
Experimental: Non-diabetic (Diazoxide)
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to non-diabetic participants.
Placebo_comparator: Non-diabetic (Placebo)
Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to non-diabetic participants.
Experimental: T2D (Diazoxide)
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants.
Placebo_comparator: T2D (Placebo)
Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.
Experimental: T2D (Diazoxide + Nicotinic Acid)
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants after lowering free fatty acids with a nicotinic acid (Niacin) infusion.
Experimental: T2D (Nicotinic Acid + placebo for diazoxide)
Pancreatic clamp study will be done after lowering free fatty acids with a nicotinic acid (Niacin) infusion in type 2 diabetic participants, and after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.
Experimental: Non-diabetic (Diazoxide + Nicotinic Acid)
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to non-diabetic participants after lowering free fatty acids with a nicotinic acid (Niacin) infusion
Experimental: Experimental: Non-diabetic (Nicotinic Acid + placebo for diazoxide)
Pancreatic clamp study will be done after lowering free fatty acids with a nicotinic acid (Niacin) infusion in non-diabetic participants, and after giving a taste-matched placebo for Diazoxide (Proglycem) toon-diabetic participants.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association, National Institutes of Health (NIH)
Leads: Meredith Hawkins

This content was sourced from clinicaltrials.gov