Diazoxide Suppression Test for Insulin Resistance
This study is looking at how the hormone insulin controls blood sugar in people with obesity and high insulin levels (hyperinsulinemia). Researchers want to understand if high insulin levels are a main problem or just a response to insulin resistance. You would take a medication called diazoxide (3 mg/kg per dose) for four days, with eight doses in total. Diazoxide works by reducing the amount of insulin your body makes. Researchers will check your fasting blood sugar and insulin levels at the beginning and after four days of taking diazoxide. The study aims to see if lowering insulin levels without changing blood sugar levels can help us understand insulin resistance better. This study is for adults aged 18-65 with a BMI between 30-45 kg/m2 and high fasting insulin levels.
- Study design
- This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized, blinded, or its phase.
- What's involved
- You would take diazoxide for four days (eight doses total) and have your fasting blood sugar and insulin levels checked at the beginning and after four days of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your fasting blood sugar and insulin levels will be measured at baseline and after 4 days of diazoxide treatment.
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NCT06606327
Diazoxide Suppression Test P&F Study
Terminated
PHASE1Ages 18–65InterventionalBasic scienceColumbia UniversityInvestigator-initiated
~1 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Diazoxide, 3 mg/kg per dose
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fasting plasma glucose
Measured over Baseline and after 4 days of diazoxide treatment
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Joshua R Cook, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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.
Eligibility criteria
Inclusion
Men and women, aged 18-65 years
Body mass index of 30-45 kg/m2
Able to understand written and spoken English and/or Spanish
Fasting hyperinsulinemia (fasting serum insulin ≥ 13 μU/mL)
Completion of the graded insulin suppression test (GIST) protocol (Group H)
Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
Pancreatic pathology, including but not limited to:
Pancreatic neoplasia, unless appropriately evaluated and considered benign and not producing hormones
Chronic pancreatitis
History of acute pancreatitis within the past 5 years
Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)
Atherosclerotic cardiovascular disease
Stable or unstable angina
Myocardial infarction
Ischaemic or hemorrhagic stroke
Peripheral arterial disease (claudication)
Use of dual antiplatelet therapy
History of percutaneous coronary intervention
Heart rhythm abnormalities (non-sinus)
Congestive heart failure of any New York Heart Association class
Severe valvular heart disease (e.g., aortic stenosis)
Pulmonary hypertension
Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \< 60 mL/min/1.73 m2), of any cause
Advanced or severe liver disease, including but not limited to:
Advanced liver fibrosis, as determined by non-invasive testing
Cirrhosis of any etiology
Autoimmune hepatitis or other rheumatologic disorder affecting the liver
Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)
Hepatocellular carcinoma
Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)
Gout
Chronic viral illness (N.B. diagnosis based only on medical history; investigators will not test for any of these viruses at any point in this study)
Hepatitis B virus (HBV), unless previously successfully eradicated with antiviral drugs that have been discontinued for at least 30 d prior to screening
Hepatitis C virus (HCV) infection, unless previously successfully eradicated with antiviral drugs that have been discontinued for at least 30 d prior to screening
Human immunodeficiency virus (HIV) infection
Active seizure disorder (including controlled with antiepileptic drugs)
Psychiatric diseases causing functional impairment that:
Are or have been decompensated within 1 year of screening, and/or
Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain/metabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium
Cushing syndrome (okay if considered in remission after treatment, provided that no exogenous corticosteroids or other ongoing treatment are required)
Adrenal insufficiency
Active malignancy, or hormonally active benign neoplasm, except allowances for:
Non-melanoma skin cancer
Differentiated thyroid cancer (AJCC Stage I only)
Clinical concern for increased risk of volume overload, including due to medications and/or heart/liver/kidney problems, as listed above
Use of certain medications currently or within 30 d prior to screening:
Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for use of drugs prescribed for indications other than the exclusionary diagnoses/purposes listed above (e.g., antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitors or angiotensin receptor blockers used for uncomplicated hypertension rather than for congestive heart failure, etc.)
Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted
History of certain weight-loss (bariatric) surgery, including:
Roux-en-Y gastric bypass
Biliopancreatic diversion
Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months
Clinical concern for alcohol overuse, including recent documented history during screening and/or participant report of regularly consuming more than 2 drinks per day for males or 1 drink per day for females.
Positive urine drug screen, with exceptions for:
Lawfully prescribed medications
Marijuana/THC positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol
History of severe infection or ongoing febrile illness within 14 days of screening
Any other disease, condition, or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and/or interfere with the analysis of study data.
Known allergy/hypersensitivity to any component of the medicinal product formulations (including sulfa drugs) or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
Concurrent enrollment in another clinical study of any investigational drug therapy within 30 days prior to screening or within 5 half-lives of an investigational agent, whichever is longer. This restriction does not apply to participants who have participated in other studies performed by the PI (Dr. Cook).
Exclusion
Unable to provide informed consent in English or Spanish
Documented weight loss of ≥ 5% of baseline within the previous 3 months
Abnormal blood pressure (including on treatment, if prescribed): Systolic blood pressure \< 90 mm Hg or \> 160 mm Hg, and/or Diastolic blood pressure \< 60 mm Hg or \> 100 mm Hg
Abnormal resting heart rate: \< 60 or ≥ 110 bpm
Sinus brady- or tachycardia that has been worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion
Abnormal screening electrocardiogram on GIST screening (or if on file, performed within previous 90 d):
Non-sinus rhythm
Heart conduction blocks
Previously unknown ischaemic changes that persist on repeat EKG:
ST elevations
T-wave inversions in a vascular distribution
Laboratory evidence of dysglycemia on GIST screening:
Hemoglobin A1c ≥ 5.7%, and/or
Fasting plasma glucose ≥ 100 mg/dL
Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential (both on the day of screening and on the first day of the DzST, prior to receipt of diazoxide doses)
Positive urine drug screen during GIST screening or on first day of DzST, except for lawfully prescribed medications and/or marijuana, provided that participant agrees to refrain from marijuana use during the period that they refrain from alcohol.
Liver function abnormalities (either of the following) on GIST screening:
Transaminases (AST or ALT) \> 3.0 x the upper limit of normal
Total bilirubin \> 1.25 x the upper limit of normal
Abnormal screening serum electrolytes (any of the following) on GIST screening:
Abnormal sodium, potassium, chloride, or bicarbonate levels that are considered potentially significant according to the clinical judgment of the PI.
Creatinine equating to estimated glomerular filtration rate \< 60 mL/min/1.73 m2
Uric acid level above the upper limit of normal
Women currently pregnant, measured by serum and/or urine β-hCG at DzST screening (and on first study visit of DzST)
Women currently breastfeeding
History of having met any of the American Diabetes Association's definitions of prediabetic state or diabetes mellitus (i.e., overt diabetes):
Hemoglobin A1c ≥ 5.7%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency
Plasma glucose ≥ 100 mg/dL after 8-h fast
Plasma glucose of ≥ 140 mg/dL at 2 h after ingestion of a 75-g glucose load
Random plasma glucose ≥ 200 mg/dL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state
History of gestational diabetes mellitus within the previous 5 years
Use of most antidiabetic medications within the 30 days prior to screening
Excluded: thiazolidinediones, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose cotransporter-2 (SGLT2) inhibitors, amylin mimetics, acarbose, insulin
What this trial measures
- Fasting plasma glucoseBaseline and after 4 days of diazoxide treatment
Plasma glucose level after overnight fast (units: mg/dL)
- Fasting serum insulinBaseline and after 4 days of diazoxide treatment
Serum insulin level after overnight fast (units: µU/mL)