Regulation of Endogenous Glucose Production by Central KATP Channels

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT03540758
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Glucose Metabolism Disorders

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Diazoxide — DRUG
    Non-diabetic participants will receive diazoxide at a dose of 4-7 mg/kg (based upon weight) during the pancreatic clamp study.
  • Nicotinic acid — DRUG
    Non-diabetic participants will receive nicotinic acid infusion based on weight (0.01 mg/kg/min) during the pancreatic clamp study.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2018
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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: 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: 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.

Primary Outcome Measure

Change in Endogenous glucose production (EGP) rate [ Time Frame: 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albert Einstein College of MedicineThe BronxNew York10461
Meredith Hawkins, M.D., M.S. (PRINCIPAL_INVESTIGATOR)

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Albert Einstein College of Medicine· The Bronx, NY

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