Regulation of Endogenous Glucose Production by Central KATP Channels

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-70
SponsorAlbert Einstein College of Medicine

About this trial

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 criteria

Qualifiers

Age: 21-70 years old

Body Mass Index (BMI) under 40 kg/m²

Negative drug screen (see below)

Normal Hemoglobin A1c (HbA1c) and fasting glucose

Disqualifiers

Age: Under 21 or over 70 years old

BMI: >40 kg/m² for Type 2 Diabetes (T2D) and Non-Diabetic (ND) subjects

Blood pressure >150/90 or <90/60 on more than one occasion

Severe polydipsia and polyuria (in subjects with T2D). Since polydipsia and polyuria are common symptoms of T2D, the distinction "severe" denotes that the subject indicates a worsening in the symptoms and/or an experience of discomfort related to the symptoms at the time of screening and/or at the time of withdrawal from the medications

Trial design

Treatments tested in this trial

  • Diazoxide
  • Nicotinic acid
  • Placebo

Treatment groups

100 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Albert Einstein College of Medicine

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

American Diabetes Association

Collaborator

Rutgers University

Collaborator

Vanderbilt University Medical Center

Collaborator