Actively Recruiting
Regulation of Endogenous Glucose Production by Central KATP Channels
Led by Albert Einstein College of Medicine · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
452 weeks
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regulation of Endogenous Glucose Production by Central KATP Channels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 21 to 70 years old
- Body Mass Index (BMI) under 40 kg/m2
- Negative drug screen
- Normal Hemoglobin A1c and fasting glucose for healthy participants
- Stable and moderate-to-poor glycemic control (HbA1c 8.0-12.0%) for type 2 diabetes participants
- Generally good health and not participating in other research studies except those by the study team
- No significant diabetic complications for type 2 diabetes participants
You will not qualify if you...
- Under 21 or over 70 years old
- Body Mass Index (BMI) over 40 kg/m2
- Blood pressure over 150/90 or under 90/60 on multiple occasions
- Severe worsening of polydipsia and polyuria symptoms in type 2 diabetes participants
- Urine microalbumin over 300 mg/g creatinine in type 2 diabetes participants
- Uncontrolled high triglycerides (over 400 mg/dL) or total cholesterol (over 300 mg/dL)
- Significant liver dysfunction or abnormal liver blood tests
- Kidney dysfunction with glomerular filtration rate under 60 mg/dL
- Clinically significant anemia, leukocytosis, leukopenia, thrombocytopenia, or thrombocytosis
- Positive urine drug screen for specific drugs affecting glucose metabolism
- Clinically significant urine or electrolyte abnormalities
- Smoking more than 10 cigarettes per day
- Excessive alcohol use above specified limits
- History of major chronic diseases including liver, kidney, heart, cancer, rheumatologic conditions, seizures, bleeding, or muscle diseases
- Past endocrine gland removal surgeries except thyroidectomy with normal thyroid function
- Pregnancy
- Participation in another study within one month prior to this study except those by the study team
- Family history of premature cardiac death
- Allergies to study medications
- Uncontrolled psychiatric disorders
- Any condition deemed unsuitable by the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
M
Meredith Hawkins, M.D., M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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