Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome

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.

Conditions

• Obesity
• Metabolic Disease

Interventions

DRUG

Colchicine 0.6Mg Cap

Colchicine 0.6 mg given twice daily

DRUG

Placebo capsules given

Placebo capsules given twice daily

DRUG

Colchicine 0.6Mg Tab

Open-label colchicine

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  lead NIH

Principal Investigators

• Jack A Yanovski, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2018-08-15

Completion

2018-08-15

FDA Drug

Yes

Countries

• United States

Study Locations