Is NCT07403604 recruiting in New York, NY?

Yes, NCT07403604 is currently recruiting participants at its New York, NY location. This hyperinsulinemia clinical trial is actively enrolling qualified participants.

How do I join the hyperinsulinemia clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hyperinsulinemia Clinical Trial in New York, NY

About This Hyperinsulinemia Study in New York

The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg/kg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology. Participants will: * Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \[mpk\]) or another 14 doses of placebo, over 7 days * Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice * Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study * Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period * Consume their total calculated daily caloric needs as divided into three meals per day Researchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.

Sponsor: Columbia University

Who Can Participate

Inclusion Criteria

Adults aged 18-65 years

Body mass index of 30-45 kg/m2

Able to understand written and spoken English and/or Spanish

Able to have pre-randomization screening labs drawn and study protocol initiated within 60 days of eligibility determination

Presence of uncomplicated metabolic dysfunction-associated steatotic liver disease (MASLD) by vibration-controlled transient elastography (VCTE)

Steatosis score of S1-S3

Fibrosis score of F0-F2 (Note that if VCTE result is available from within past 6 months, then do not have to repeat VCTE for study purposes)

Evidence of insulin resistance, represented by any or all of the following criteria:

Meeting either of the American Diabetes Association's definitions for prediabetes or impaired fasting glucose (IFG) on screening labs:

Prediabetes: Hemoglobin A1c 5.7-6.4%

IFG: plasma glucose of 100-125 mg dL-1 after ≥ 8-h fast

Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73

Fasting hyperinsulinemia (fasting insulin level ≥ 13 μU/mL) on screening labs

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.

Exclusion Criteria

Unable to provide informed consent in English or Spanish

Concerns arising at screening visit (any of the following):

Documented weight loss of ≥ 5.0% of baseline within the previous 3 months

Abnormal blood pressure (including on treatment, if prescribed)

Systolic blood pressure (SBP) \< 90 mm Hg or \> 160 mm Hg, and/or

Diastolic blood pressure (DBP) \< 60 mm Hg or \> 100 mm Hg

Resting heart rate \< 55 bpm or ≥ 110 bpm

Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)

Laboratory evidence of diabetes mellitus:

Hemoglobin A1c ≥ 6.5%, and/or

Fasting plasma glucose ≥ 126 mg/dL

Positive qualitative serum β-human chorionic gonadotropin (β-hCG, i.e., pregnancy test) in women of childbearing potential

Liver function abnormalities: transaminases (aspartate aminotransferase or alanine aminotransferase) \> 3.0 x the upper limit of normal, and/or total bilirubin \> 1.25 x the upper limit of normal

Abnormal screening fasting triglycerides \> 500 mg/dL

Abnormal screening serum electrolytes that are considered clinically significant according to the clinical judgment of the PI

Creatinine equating to estimated glomerular filtration rate \< 60 mL/min/1.73 m2

Abnormal screening blood counts (any of the following):

Hemoglobin \< 10 g/dL

White blood cell count below the lower limit of normal for sex

Platelet count below the lower limit of normal for sex

Uric acid level above the upper limit of normal

Reproductive concerns

Women currently pregnant (tested by serum and/or urine β-hCG)

Women currently breastfeeding

Concerns related to glucose metabolism

History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):

Hemoglobin A1c ≥ 6.5%

Plasma glucose ≥ 126 mg/dL after 8-h fast

Plasma glucose of ≥ 200 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 antidiabetic medications except metformin within the 90 days prior to screening

Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)

Concerns related to lipid metabolism

Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia

Use of fibrates, prescription-strength omega-3 fatty acids, or high-dose niacin within the 90 days prior to screening:

Known, documented history (i.e., not to be newly screened/tested for study purposes), at the time of screening, of any of the following medical conditions:

Pancreatic pathology, including but not limited to neoplasia, pancreatitis, pancreatectomy

Cardiovascular disease (N.B. uncomplicated hypertension is not exclusionary)

Atherosclerotic cardiovascular disease: stable or unstable angina, myocardial infarction, ischaemic or hemorrhagic stroke, or transient ischaemic attack, peripheral arterial disease (claudication), use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor), history of percutaneous coronary intervention

Heart rhythm abnormalities

Congestive heart failure of any New York Heart Association class

Symptomatic 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

Chronic liver disease other than uncomplicated MASLD, including but not limited to:

Advanced liver fibrosis, as determined by non-invasive testing, including fibrosis scores of F3-F4 on VCTE

Cirrhosis of any etiology

Autoimmune hepatitis or other rheumatologic disorder affecting the liver

Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)

Chronic liver infection (e.g., viral hepatitis, parasitic infestation)

Hepatocellular carcinoma

Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)

Chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Malabsorptive conditions

Active seizure disorder (including controlled with antiepileptic drugs)

Psychiatric diseases that are or have been decompensated within 1 year of screening, and/or require use of antipsychotic drugs associated with significant weight gain/metabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium

Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

Other clinically significant endocrinopathies

Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation

Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)

Clinical concern for increased risk of volume overload or hypotension (SBP \<90 and/or DBP \<60 mm Hg), including due to medications and/or heart/liver/kidney problems, as listed above

Use of certain medications currently or within 90 d prior to screening:

Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:

Statins for primary prevention of cardiovascular disease

Use of drugs prescribed for indications other than the exclusionary diagnoses/purposes listed above (e.g., non-hydantoin antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitor/angiotensin receptor blocker used for uncomplicated hypertension rather than for congestive heart failure, etc.)

Vasodilating drugs for any indication: hydralazine, nitrates, phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), minoxidil (oral)

Phenytoin or fosphenytoin for any indication

Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted

History of certain weight-loss (bariatric) surgeries, including:

Roux-en-Y gastric bypass

Biliopancreatic diversion

Restrictive procedures (lap band, sleeve gastrectomy) performed within past year

Clinical concern for alcohol overuse, including based on chart review and/or by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females

Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and/or nicotine vaping more than 1 day per week

Positive urine drug screen, except for lawfully prescribed medications or marijuana/tetrahydrocannabinol positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol)

Atypical circadian rhythm, such as due to night shift work, within 30 days of screening or expected within 30 days of each treatment period

History of severe infection or ongoing febrile illness within 14 days of screening

Any other disease or 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), other biologics, intravenous (IV) infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.

Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 5 half-lives of an investigational agent or biologic

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07403604) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hyperinsulinemia Treatment Options in New York, NY

If you're searching for hyperinsulinemia treatment options in New York, NY, this clinical trial (NCT07403604) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hyperinsulinemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hyperinsulinemia clinical trials near you to find additional studies recruiting in your area.

Hyperinsulinemia Clinical Trial in New York, NY

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