Is NCT03540758 recruiting in The Bronx, NY?

Yes, NCT03540758 is currently recruiting participants at its The Bronx, NY location. This diabetes mellitus clinical trial is actively enrolling qualified participants.

How do I join the diabetes mellitus clinical trial in The Bronx?

To join this clinical trial in The Bronx, 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 The Bronx 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.

Diabetes Mellitus Clinical Trial in The Bronx, NY

About This Diabetes Mellitus Study in The Bronx

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.

Sponsor: Albert Einstein College of Medicine

Who Can Participate

Inclusion Criteria

For healthy (non-diabetic) participants:

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

Exclusion Criteria

Not participating in any other research study besides those done by the study team For T2D participants:

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 Criteria:

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

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 The Bronx?

Yes, this clinical trial (NCT03540758) has an active research site in The Bronx, 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.

Diabetes Mellitus Treatment Options in The Bronx, NY

If you're searching for diabetes mellitus treatment options in The Bronx, NY, this clinical trial (NCT03540758) 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 The Bronx research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetes mellitus 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 diabetes mellitus clinical trials near you to find additional studies recruiting in your area.

Diabetes Mellitus Clinical Trial in The Bronx, NY

Expert Care in The Bronx

IRB Approved

No-Cost Care

Apply for This The Bronx Location

Why Participate?

Simple Process