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NCT02153983 · ClinicalTrials.gov registry record · Phase 1
Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT02153983: Completed Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT02153983 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153983, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
Background: \- Being overweight may cause low-level inflammation. This inflammation may cause some of the medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study will test whether a medication called colchicine can improve metabolism in adults who are overweight but have not yet developed diabetes. Objectives: \- To learn whether colchicine improves sugar regulation and metabolism. Eligibility: \- Healthy overweight adults18 to 100 years old. Design: * Participants must fast before each visit, including the screening visit. * Participants will be screened with blood tests,urine tests, medical history, and physical exam. They will have to drink sugar water, and have blood drawn to find out if they are healthy. * For visit 1, participants will have a medical history and physical exam and answer questions. They will have blood taken with an intravenous (IV) line, give urine sample, and give 2 stool samples.. * Also, subjects will get sugar water through one IV. Blood will be drawn from the other. This measures sugar and insulin levels. During this, participants will lie in a bed and can watch TV. * Participants will have a full-body X-ray, lying on a table while a camera passes over them. They will also have an abdominal CT scan, lying on a table that moves through a ring that takes pictures. * Participants will have a small fat tissue sample taken from their abdomen. It is like getting a mini-liposuction. * Participants will be given the study drug or placebo. They will take it twice daily for 3 months. * For visit 2, participants will have blood tests, urine tests, medical history, and physical exam. * For visit 3, participants will repeat the tests in visit 1.
Primary Outcome
Change (3 month minus minus baseline) in insulin sensitivity value, calculated from frequently-sampled intravenous glucose tolerance tests by Bergman's Minimal Model using intent-to-treat. Higher values represent a better outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally.
Interventions
- DRUG Colchicine 0.6Mg Cap
- DRUG Placebo capsules given
- DRUG Colchicine 0.6Mg Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT02153983 record still lists
NCT02153983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 3 interventions - of which Colchicine 0.6Mg Cap is the first listed.
NCT02153983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02153983 about?
NCT02153983 is a clinical study titled "Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome". Background: \- Being overweight may cause low-level inflammation. This inflammation may cause some of the medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study will test whether a medication called colchicine can improve metabolism in adults who are overweight ...
What is the current status of trial NCT02153983?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2014-05-31. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT02153983?
The interventions under investigation include: Colchicine 0.6Mg Cap (DRUG), Placebo capsules given (DRUG), Colchicine 0.6Mg Tab (DRUG).
Who is sponsoring clinical trial NCT02153983?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02153983's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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