Trial · NCT02153983
Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome
NCT02153983, Phase 1, Phase 2, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome. Trials, record NCT02153983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02153983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome
- NCT number
- NCT02153983
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Obesity, Metabolic Disease
- Interventions
- Colchicine 0.6Mg Cap, Placebo capsules given, Colchicine 0.6Mg Tab
- First posted
- 2014-06-03
- Last updated
- 2019-08-13
- Results first posted
- 2019-08-13
- Limitations and caveats
- Pilot trial to determine power calculations, so no definitive conclusions should be reached from this trial.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Insulin Sensitivity From FSIVGTT | Baseline to 3 months | 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. |
| Secondary | Change in HOMA-IR Index | Baseline to 3 months | Change (3 month minus minus baseline) in calculated homeostasis model of insulin sensitivity, calculated from derived from fasting glucose and insulin values = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5) using intent-to-treat. Higher values represent a worse outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally. |
| Secondary | Changes in C-reactive Protein | Baseline to 3 months | Change (3 month minus minus baseline) in High-Sensitivity C-reactive protein concentrations using intent-to-treat. Higher values represent a worse outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Insulin Sensitivity From FSIVGTT | Baseline to 3 months | Randomized trial has 2 groups, open label only one group | 10^-5*min^-1*mU^-1*mL | MEAN |
| SECONDARY | Change in HOMA-IR Index | Baseline to 3 months | RCT has colchicine and placebo groups, open label is colchicine only. | units on a scale | MEAN |
| SECONDARY | Changes in C-reactive Protein | Baseline to 3 months | Patients randomized to colchicine or placebo for randomized controlled trial, but only open-label colchicine for patients with type 2 diabetes | mg/L | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Insulin Sensitivity From FSIVGTT | Obese Adults With Metabolic Syndrome Randomized to Placebo | 0.20 | 95% Confidence Interval -0.12 to 1.58 | 10^-5*min^-1*mU^-1*mL | |
| Change in Insulin Sensitivity From FSIVGTT | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 0.41 | 95% Confidence Interval -0.90 to 1.72 | 10^-5*min^-1*mU^-1*mL | |
| Change in Insulin Sensitivity From FSIVGTT | Open Label Patients With Type 2 Diabetes | -0.45 | 95% Confidence Interval -1.58 to 0.61 | 10^-5*min^-1*mU^-1*mL | |
| Change in HOMA-IR Index | Obese Adults With Metabolic Syndrome Randomized to Placebo | 1.1 | 95% Confidence Interval -0.1 to 7.6 | units on a scale | |
| Change in HOMA-IR Index | Obese Adults With Metabolic Syndrome Randomized to Colchicine | -0.3 | 95% Confidence Interval -1.1 to 1.1 | units on a scale | |
| Change in HOMA-IR Index | Open Label Patients With Type 2 Diabetes | 8.4 | 95% Confidence Interval 0.05 to 16.8 | units on a scale | |
| Changes in C-reactive Protein | Obese Adults With Metabolic Syndrome Randomized to Placebo | 0.5 | 95% Confidence Interval -0.9 to 1.8 | mg/L | |
| Changes in C-reactive Protein | Obese Adults With Metabolic Syndrome Randomized to Colchicine | -2.8 | 95% Confidence Interval -4.1 to -1.5 | mg/L | |
| Changes in C-reactive Protein | Open Label Patients With Type 2 Diabetes | -3.7 | 95% Confidence Interval -10.4 to 3.0 | mg/L |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Obese Adults With Metabolic Syndrome Randomized to Placebo | 19 | |
| Overall Study | STARTED | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 21 | |
| Overall Study | STARTED | Open Label Patients With Type 2 Diabetes | 4 | |
| Overall Study | STARTED | Evaluation Only Non-obese Adults | 13 | |
| Overall Study | STARTED | Evaluation Only Obese Adults | 19 | |
| Overall Study | STARTED | Evaluation Only Adults With Type 2 Diabetes | 1 | |
| Overall Study | COMPLETED | Obese Adults With Metabolic Syndrome Randomized to Placebo | 19 | |
| Overall Study | COMPLETED | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 18 | |
| Overall Study | COMPLETED | Open Label Patients With Type 2 Diabetes | 2 | |
| Overall Study | COMPLETED | Evaluation Only Non-obese Adults | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal | Gastrointestinal disorders | Obese Adults With Metabolic Syndrome Randomized to Placebo | 14 | 19 | 14 |
| other | Gastrointestinal | Gastrointestinal disorders | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 13 | 21 | 13 |
| other | Gastrointestinal | Gastrointestinal disorders | Open Label Patients With Type 2 Diabetes | 1 | 4 | 4 |
| other | Gastrointestinal | Gastrointestinal disorders | Evaluation Only Non-obese Adults | 0 | 13 | 0 |
| other | Gastrointestinal | Gastrointestinal disorders | Evaluation Only Obese Adults | 0 | 19 | 0 |
| other | Gastrointestinal | Gastrointestinal disorders | Evaluation Only Adults With Diet-controlled Type 2 Diabetes | 0 | 1 | 0 |
| other | Upper Respiratory Tract | Infections and infestations | Obese Adults With Metabolic Syndrome Randomized to Placebo | 11 | 19 | 11 |
| other | Upper Respiratory Tract | Infections and infestations | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 6 | 21 | 6 |
| other | Upper Respiratory Tract | Infections and infestations | Open Label Patients With Type 2 Diabetes | 1 | 4 | 4 |
| other | Upper Respiratory Tract | Infections and infestations | Evaluation Only Non-obese Adults | 0 | 13 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obese Adults With Metabolic Syndrome Randomized to Placebo | 0 | 19 |
| Total, all-cause mortality | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 0 | 21 |
| Total, all-cause mortality | Open Label Patients With Type 2 Diabetes | 0 | 4 |
| Total, all-cause mortality | Evaluation Only Non-obese Adults | 0 | 13 |
| Total, all-cause mortality | Evaluation Only Obese Adults | 0 | 19 |
| Total, all-cause mortality | Evaluation Only Adults With Diet-controlled Type 2 Diabetes | 0 | 1 |
| Total, other adverse events | Obese Adults With Metabolic Syndrome Randomized to Placebo | 16 | 19 |
| Total, other adverse events | Obese Adults With Metabolic Syndrome Randomized to Colchicine | 15 | 21 |
| Total, other adverse events | Open Label Patients With Type 2 Diabetes | 2 | 4 |
| Total, other adverse events | Evaluation Only Non-obese Adults | 0 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| ZIAHD000641 | Physiology, Psychology, and Genetics of Obesity | YANOVSKI, JACK A. | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2009 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02153983
GET https://conductscience.org/api/trials/v1/NCT02153983/events?page=2