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NCT00027456 · ClinicalTrials.gov registry record · Phase 2
Leptin to Treat Severe Insulin Resistance - Pilot Study
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00027456 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 2 participants.
The verdict
NCT00027456, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This pilot study will evaluate the safety and effectiveness of leptin therapy in two children with severe insulin resistance syndrome. Patients with this condition often have high blood sugar levels and may have hormone imbalances, a constant feeling of warmth, fertility problems, large appetite, and enlarged liver due to fat accumulation. Leptin is a hormone produced by fat cells. It influences appetite, affects levels of reproductive hormones, and possibly manages how the body reacts to insufficient food. Certain people with severe insulin resistance syndromes have decreased amounts of fat tissue and make little or no leptin. A 13-year-old male and an 11-year-old female with severe insulin resistance will participate in this study. They will have the following tests and procedures before beginning 4 months of leptin therapy: * Insulin tolerance test - measures blood sugar levels after intravenous (IV) administration of insulin. Blood samples are collected through the IV tube at various intervals during the 1-hour test. * Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. * Fasting blood tests - to measure blood count, blood lipids, and various hormones and assess liver function. * Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to calculate how many calories are required to maintain resting body functions. * Magnetic resonance imaging of the liver and other organs, and of muscle and fat. * Pelvic ultrasound in female patient - to detect ovarian cysts. * Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds over the arms and abdomen to estimate body fat content. * Oral glucose tolerance test - measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected through an IV tube in an arm vein at various intervals during the 3-hour test. * Intravenous glucose tolerance test - measures t
Interventions
- DRUG Leptin A-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2001-11 |
| Est. Completion | 2002-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00027456
The ClinicalTrials.gov registry entry for NCT00027456 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Leptin A-100 is the first listed.
NCT00027456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00027456 about?
NCT00027456 is a clinical study titled "Leptin to Treat Severe Insulin Resistance - Pilot Study". This pilot study will evaluate the safety and effectiveness of leptin therapy in two children with severe insulin resistance syndrome. Patients with this condition often have high blood sugar levels and may have hormone imbalances, a constant feeling of warmth, fertility problems, large appetite, an...
What is the current status of trial NCT00027456?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2001-11. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00027456?
The interventions under investigation include: Leptin A-100 (DRUG).
Who is sponsoring clinical trial NCT00027456?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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