Actively Recruiting

Phase 2
Age: 21Years - 70Years
All Genders
Healthy Volunteers
NCT03540758

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

Age: 21Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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