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NCT05017571 · ClinicalTrials.gov registry record · Phase 2
Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
A Phase 2 study of Obesity and Inflammation, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT05017571: Completed Phase 2 study of Obesity and Inflammation, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT05017571 is a Phase 2 study of Obesity and Inflammation that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 152 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05017571, a Phase 2 study of Obesity and Inflammation, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help. Objective: To learn if colchicine can improve metabolism in people who have high body weight, increased inflammation, and high insulin in the blood but who have not yet developed high blood sugar. Eligibility: People aged 12 and older with high body weight who may have increased inflammation and high insulin in the blood. Healthy adult volunteers are also needed. Design: Participants will be screened with the following: Medical history Physical exam Fasting blood tests Urine tests Electrocardiogram Dual energy x-ray absorptiometry (They will lie on a table while a camera passes over their body.) Stool sample and 24-hour food diary (optional) Participants will have 3 study visits and 3 phone check-ins. At visits, they will repeat some screening tests. Healthy volunteers will have the baseline visit only. They will not get the study drug. At the baseline visit, participants will have an Oral Glucose Tolerance Test (OGTT). For this, they will drink a sweet liquid and then give blood samples. They will get a 12-week supply of the study drug or placebo to take daily by mouth. Participants will have study visits 6 weeks and 12 weeks after they started taking the study drug. At the 12-week visit, they will repeat the OGTT. Participation will last for 3 (Omega) to 4 months. ...
Primary Outcome
HOMA-IR is calculated from fasting (f) insulin (I) and glucose (G): Gf (in mg/dL) x If in ( (Micro)IU/mL/ 405).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Colchicine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT05017571 record still lists
NCT05017571 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05017571 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05017571 about?
NCT05017571 is a clinical study titled "Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity". Background: About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help. Objective: To l...
What is the current status of trial NCT05017571?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2021-11-08. Estimated completion is 2025-09-02.
What conditions does trial NCT05017571 study?
This clinical trial studies the following conditions: Obesity, Inflammation, Insulin Resistance.
What interventions are being tested in trial NCT05017571?
The interventions under investigation include: Placebo (DRUG), Colchicine (DRUG).
Who is sponsoring clinical trial NCT05017571?
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.
Where is trial NCT05017571 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05017571's enrollment target sits among peer trials
152 368th of 1053 higher than 686 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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