Is NCT00001987 recruiting in Bethesda, MD?

Yes, NCT00001987 is currently recruiting participants at its Bethesda, MD location. This diabetes mellitus clinical trial is actively enrolling qualified participants.

How do I join the diabetes mellitus clinical trial in Bethesda?

To join this clinical trial in Bethesda, 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 Bethesda 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 Bethesda, MD

About This Diabetes Mellitus Study in Bethesda

The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus. Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin resistance refers to conditions like diabetes when insulin does not work properly. In this study researchers would like to compare patients with diabetes and other forms of insulin resistance to normal individuals. The study will investigate how insulin attaches to cells. Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if further genetic testing is necessary. In addition some patients may be asked not to eat for up to 72 hours prior to testing.

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who Can Participate

Inclusion Criteria

Three categories of subjects will be included in this study:

Patients with evidence for insulin resistance or a disorder associated with severe insulin resistance, including:

Patients with various syndromes of lipodystrophy

Patients with known or suspected mutations on the insulin receptor gene

Patients with known or suspected autoantibodies to the insulin receptor

Patients with other severe forms of insulin resistance

Family members of patients, above

Healthy control subjects without insulin resistance Inclusion criteria for each group of subjects are given below:

Patients with evidence for severe insulin resistance or a disorder associated with severe insulin resistance must meet all of the following criteria:

Suspected severe insulin resistance, or a disorder associated with severe insulin resistance, as evidenced by one or more of the following:

Hyperinsulinemia (i.e. fasting insulin \>30microU/mL)

High insulin requirement (\> 2 units per kg per day or \> 200 units total per day)

Phenotypic features suggesting a defect in glucose/lipid metabolism:

Acanthosis nigricans

Lipodystrophy/abnormal fat distribution

Fatty liver

Known or suspected mutations of the insulin receptor gene

Known or suspected autoantibodies to the insulin receptor

Age \>= 6 months

Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Family members of patients, above (either affected or unaffected) must meet all of the following criteria:

Biological relatives of patients in category (1) in whom a genetic cause of insulin resistance is known or suspected.

Age \>= 6 months

Ability of subject (and/or legal guardian, for minor subjects) to understand and the willingness to sign a written informed assent/consent document.

Healthy control subjects Cohort 1 must meet all of the following criteria.

Ability of subject (and/or legal guardian, for minor subjects) to understand and the willingness to sign a written informed assent/consent document.

In good general health with no known active medical conditions as evidenced by medical history

Age \>= 12 years

Healthy control subjects Cohort 2. Subjects from Cohort 1 may be included in Cohort 2 if they meet the following ADDITIONAL inclusion criteria.

Fasting glucose \<100 mg/dL

HbA1c \<5.7%

Fasting triglycerides \<150 mg/dL

Fasting insulin \<30 mcU/mL

BMI \<27 kg/m\^2 or \<90th percentile for age/sex (whichever is lower)

Exclusion Criteria

Patients with evidence for insulin resistance or a disorder associated with severe insulin resistance --none

Family members of patients, above --Pregnant at the time of enrollment

Healthy control subjects Cohort 1

Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.

Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g. niacin, fish oil, red yeast rice)

History of diabetes or abnormal glucose tolerance

Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent/assent, or to comply with study procedures

Pregnant or lactating

Healthy control subjects Cohort 2. Subjects from Cohort 1 may NOT be included in Cohort 2 if they have any of the following ADDITIONAL exclusion criteria.

Abnormal screening labs, including the following:

ALT or AST more than 1.5 times the upper limit of normal

Clinically significant anemia

Low eGFR (\<60 mL/min/1.73m\^2)

Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data

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 Bethesda?

Yes, this clinical trial (NCT00001987) has an active research site in Bethesda, MD 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 Bethesda, MD

If you're searching for diabetes mellitus treatment options in Bethesda, MD, this clinical trial (NCT00001987) 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 Bethesda 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 Bethesda, MD

Expert Care in Bethesda

IRB Approved

No-Cost Care

Apply for This Bethesda Location

Why Participate?

Simple Process