Trial Outcomes & Findings for Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome (NCT NCT02153983)

Last Updated: 2019-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2019-08-13

Participant Flow

213 adults were screened in the clinic and signed consent forms, of whom 77 were found eligible and studied with protocols.

Participant milestones

Participant milestones
Measure	Obese Adults With Metabolic Syndrome Randomized to Placebo Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily	Obese Adults With Metabolic Syndrome Randomized to Colchicine Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily	Open Label Patients With Type 2 Diabetes Patients with diet-controlled type 2 dabetes, given open-label colchicine tablets 0.6 mg twice-daily	Evaluation Only Non-obese Adults Adults without obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.	Evaluation Only Obese Adults Adults with obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.	Evaluation Only Adults With Type 2 Diabetes Adults with Diet-controlled Type 2 Diabetes, seen only for an evaluation visit, not given any medication and not followed longitudinally.
Overall Study STARTED	19	21	4	13	19	1
Overall Study COMPLETED	19	18	2	13	19	1
Overall Study NOT COMPLETED	0	3	2	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Adults With Metabolic Syndrome Randomized to Placebo n=19 Participants Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation given twice daily	Obese Adults With Metabolic Syndrome Randomized to Colchicine n=21 Participants Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily	Open Label Patients With Type 2 Diabetes n=4 Participants Adults with diet-controlled type 2 diabetes, treated with open-label Colchicine 0.6Mg Tab	Evaluation Only Non-obese Adults n=13 Participants Adults without obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.	Evaluation Only Obese Adults n=19 Participants Adults with obesity, seen only for an evaluation visit, not given any medication and not followed longitudinally.	Evaluation Only Adults With Diet-controlled Type 2 Diabetes n=1 Participants Adults with Diet-controlled Type 2 Diabetes, seen only for an evaluation visit, not given any medication and not followed longitudinally.	Total n=77 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 10.0 • n=5 Participants	47.3 years STANDARD_DEVIATION 13.4 • n=7 Participants	42.8 years STANDARD_DEVIATION 13.4 • n=5 Participants	37.2 years STANDARD_DEVIATION 13.5 • n=4 Participants	46.4 years STANDARD_DEVIATION 11.9 • n=21 Participants	47.9 years n=10 Participants	44.3 years STANDARD_DEVIATION 12.3 • n=115 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	15 Participants n=21 Participants	0 Participants n=10 Participants	58 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	19 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	19 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	15 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants	16 Participants n=21 Participants	1 Participants n=10 Participants	56 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	24 Participants n=115 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	0 Participants n=10 Participants	28 Participants n=115 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	14 Participants n=115 Participants
High-Sensitivity C-Reactive Protein	6.7 mg/L STANDARD_DEVIATION 4.2 • n=5 Participants	8.1 mg/L STANDARD_DEVIATION 7.4 • n=7 Participants	9.63 mg/L STANDARD_DEVIATION 6.17 • n=5 Participants	0.77 mg/L STANDARD_DEVIATION 0.80 • n=4 Participants	3.08 mg/L STANDARD_DEVIATION 2.67 • n=21 Participants	1.4 mg/L n=10 Participants	5.41 mg/L STANDARD_DEVIATION 5.49 • n=115 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Randomized trial has 2 groups, open label only one group

Outcome measures

Outcome measures
Measure	Obese Adults With Metabolic Syndrome Randomized to Placebo n=19 Participants Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation, given twice daily	Obese Adults With Metabolic Syndrome Randomized to Colchicine n=21 Participants Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily	Open Label Patients With Type 2 Diabetes n=4 Participants Patients With Type 2 Diabetes given open-label treatment with colchicine 0.6 Mg Tab
Change in Insulin Sensitivity From FSIVGTT	0.20 10^-5min^-1mU^-1*mL Interval -0.12 to 1.58	0.41 10^-5min^-1mU^-1*mL Interval -0.9 to 1.72	-0.45 10^-5min^-1mU^-1*mL Interval -1.58 to 0.61

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: RCT has colchicine and placebo groups, open label is colchicine only.

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.

Outcome measures

Outcome measures
Measure	Obese Adults With Metabolic Syndrome Randomized to Placebo n=19 Participants Experimental treatment with placebo capsules identical in appearance to the experimental colchicine preparation, given twice daily	Obese Adults With Metabolic Syndrome Randomized to Colchicine n=21 Participants Experimental treatment with colchicine capsules identical in appearance to the experimental placebo preparation given twice daily	Open Label Patients With Type 2 Diabetes n=4 Participants Patients With Type 2 Diabetes given open-label treatment with colchicine 0.6 Mg Tab
Change in HOMA-IR Index	1.1 units on a scale Interval -0.1 to 7.6	-0.3 units on a scale Interval -1.1 to 1.1	8.4 units on a scale Interval 0.05 to 16.8

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Patients randomized to colchicine or placebo for randomized controlled trial, but only open-label colchicine for patients with type 2 diabetes

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.