Phillip Gorden, M.D., Director Emeritus

Clinical Trials

Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:

  • Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
  • Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants are not being recruited or enrolled.
  • Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate. The study is not open to everyone who meets the eligibility criteria.
  • Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.

Studies Seeking Patients

Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance

Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control withconventional therapies, leading to early morbidity and mortality. We hypothesize that recombinant leptin (metrel eptin) in these patients will improve glycemia control. Objectives: Primary Objective: To determine if 1 year of metreleptin will improve glycemia control in patients with genetic defects of the insulin receptor. Secondary Objectives: To determine mechanisms by which metreleptin improves glycemia. Endpoints: Primary Endpoint: Hemoglobin A1c. Secondary Endpoints: fasting plasma glucose, fasting insulin/C-peptide, glucose/insulin/C-peptide area under the curve during oral glucose tolerance test. Study Population: 20 male or female patients with mutations of the insulin receptor, age (Bullet)5 years, at the NIH Clinical Center. Description of Sites/Facilities Enrolling Participants: Description of Study Intervention: NIH Clinical Center Open label study of metreleptin, 0.2 mg/kg/day (max dose 0.24 mg/kg/day).

The trial is Open with a status of Recruiting.

Investigator: Rebecca J Brown, M.D.

Referral Contacts: (301) 402-6371

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Diagnosing and Treating Low Blood Sugar Levels

Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia. Patients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed.

The trial is Open with a status of Recruiting.

Investigator: Ranganath Muniyappa, M.D.

Referral Contacts: (301) 402-1880

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Genetic Studies of Insulin and Diabetes

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.

The trial is Open with a status of Recruiting.

Investigator: Rebecca J Brown, M.D.

Referral Contacts: (301) 402-6371

Share this Trial: Email