Back to search results

Understanding Glucose Production in Diabetes

This study aims to understand how a medication called diazoxide affects the liver's ability to make sugar (endogenous glucose production or EGP), especially in people with Type 2 Diabetes (T2D). Researchers believe that the brain plays a role in regulating blood sugar levels, and this process might be impaired in T2D. You may be eligible if you are between 21 and 70 years old, with a BMI under 40, and are either healthy or have T2D. The study will measure changes in EGP rate over 7-hour infusions, across 4 days, up to a year. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. Healthy participants will receive diazoxide, nicotinic acid, or a placebo in a randomized, single-blinded fashion.
What's involved
Participants will undergo a "pancreatic clamp" study, which involves intravenous infusions of glucose and insulin, and periodic blood samples. This will occur during 7-hour infusions, 4 days in total, separated by at least one month.
Compensation
Not stated in the trial record.
Follow-up
Changes in endogenous glucose production rate will be measured over 7-hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03540758

Regulation of Endogenous Glucose Production by Central KATP Channels

Recruiting
PHASE2Ages 21–70InterventionalBasic science
Albert Einstein College of Medicine
~100 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:DiazoxideNicotinic acidPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Endogenous glucose production (EGP) rate
Measured over 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration

Conditions

Diabetes Mellitus
Glucose Metabolism Disorders

Explore related trials

Diabetes MellitusGlucose Metabolism Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Meredith Hawkins, M.D., M.S. · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine

Who to contact

Meredith Hawkins, M.D., M.S.
[email protected]
718-430-2903
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age: 21-70 years old
Body Mass Index (BMI) under 40 kg/m\^2
Negative drug screen (see below)
Normal Hemoglobin A1c (HbA1c) and fasting glucose
In general good health (see below for exclusions)
Not participating in any other research study besides those done by the study team
Age: 21-70 years old
BMI under 40 kg/m\^2
Stable and moderate-to-poor glycemic control (HbA1c: 8.0-12.0%)
Negative drug screen (see below)
Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease (urinary microalbumin \<100 μg/dl) or severe peripheral neuropathy (including cardiovascular and gastrointestinal autonomic neuropathy) per medical history
Diabetic subjects will be otherwise in good health (see below for exclusions), taking no medications that might affect study eligibility based on review by study doctor, and not participating in any other research study besides those done by the study team

Exclusion

Age: Under 21 or over 70 years old
BMI: \>40 kg/m\^2 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
Urine microalbumin: \>300 mg/g of creatinine (in subjects with T2D)
Uncontrolled hyperlipidemia defined as Triglycerides (TG) \> 400 mg/dL and/or Total Cholesterol \>300 mg/dL
Clinically significant liver dysfunction including thrombocytopenia (platelets \<100,000/uL), anemia (as below), hypoalbuminemia (\<3.5 g/dL), coagulopathy (INR \> 1.5), and/or liver enzymes more than 3 times the upper limit of normal
Clinically significant kidney dysfunction, Glomerular Filtration Rate (GFR): \<60 mg/dL
Clinically significant anemia. Prospective subjects with hemoglobin below the lower limit of 12 g/dl for for men and 11 g/dL for women will be assessed with history and physical exam to rule out clinically significant anemia, defined as an individual with symptoms (e.g., fatigue, weakness, shortness of breath, palpitations), signs (pallor, brittle nails etc.), or currently under treatment for anemia. In the absence of a documented hemoglobin decrease or iron deficiency, subjects will not be excluded
Clinically significant leukocytosis or leukopenia
Clinically significant thrombocytopenia or thrombocytosis
Coagulopathy
Urine drug screen positive for any of the following: amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone, phencyclidine (PCP). Amphetamines, oxycodone, opiates, methadone, and benzodiazepines have been shown to affect glucose metabolism (increased glycemia, increased fasting insulin levels, delayed insulin response to food ingestion, insulin deficiency). As the drug test available in the Clinical Research Center (CRC) is a 7-drug panel, the investigator team cannot specifically choose which drugs are screened for. Additionally, in the interest of selecting patients on the basis of their reliability and dependability, the investigator team would like to exclude participants using illicit drugs. Occasional use of cannabis (once or twice per week) is not an exclusion factor. If the test is read as "indeterminate" it will be repeated at the bedside and an additional sample will be sent to the lab. Decision to enroll subject that day prior to results from lab being available will be decided on a case-by-case basis, i.e., when all previous drug testing had been negative and clinical suspicion is very low
Urinalysis: Clinically significant abnormalities
Clinically significant electrolyte abnormalities
Smoking \>10 cigarettes/day
Alcohol: Men \>14 drinks/week or \>4 drinks/day, Women \>7 drinks/week or \>3 drinks/day
History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease
Surgeries that involve removal of endocrine glands except for thyroidectomy (if euthyroid on thyroid hormone replacement - if such history free thyroxine (fT4) and Thyroid Stimulating Hormone (TSH) will be checked)
Pregnant women
Subject enrolled in another study less than one month prior to the anticipated start date of the proposed study, besides those done by our group
Family history of premature cardiac death
Allergies to medication administered during study
Uncontrolled psychiatric disorders
Any condition which in the opinion of the PI makes the subject ill suited for participation in the study

What this trial measures

  • Change in Endogenous glucose production (EGP) rate7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration

    Rates of EGP (a measure of the body's production of sugar) will be measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., placebo, diazoxide, nicotinic acid, nicotinic acid/diazoxide), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Measurement of blood glucose concentrations will either be performed with a Precision Xceed Pro glucometer or an Analox glucose analyzer in the study room. Increased EGP is the major cause of fasting hyperglycemia. EGP will be determined by subtracting the rates of glucose infusion from the tracer-derived Rates of glucose appearance (Ra). Rates of change in EGP will be reported in concentration/time and summarized by study arm using basic descriptive statistics.