CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
Colchicine 0.6Mg Cap +2 moredrug
Likely dose
Colchicine 0.6Mg Capfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02153983
NCT02153983Phase 2Completed

Pilot Study of the Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Jun 3, 2014·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating Colchicine 0.6Mg Cap, Placebo capsules given, and 1 other intervention for Obesity and Metabolic Disease. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 3, 2014
Enrollment StartMay 31, 2014
Primary CompletionAug 15, 2018
TodayJul 1, 2026
Enrollment to primary: 4.2 yearsPosted 12.1 years ago

Interventions

Colchicine 0.6Mg Capdrug

Colchicine 0.6 mg given twice daily

Placebo capsules givendrug

Placebo capsules given twice daily

Colchicine 0.6Mg Tabdrug

Open-label colchicine