Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity

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. ...

Timeline

Start

2021-11-08

Primary completion

2025-09-02

Completion

2025-09-02

Publications

• Background Demidowich AP, Davis AI, Dedhia N, Yanovski JA. Colchicine to decrease NLRP3-activated inflammation and improve obesity-related metabolic dysregulation. Med Hypotheses. 2016 Jul;92:67-73. doi: 10.1016/j.mehy.2016.04.039. Epub 2016 Apr 25.
• Background Demidowich AP, Levine JA, Apps R, Cheung FK, Chen J, Fantoni G; CHI Consortium; Patel TP, Yanovski JA. Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial. Int J Obes (Lond). 2020 Aug;44(8):1793-1799. doi: 10.1038/s41366-020-0598-3. Epub 2020 May 27.
• Background Demidowich AP, Levine JA, Onyekaba GI, Khan SM, Chen KY, Brady SM, Broadney MM, Yanovski JA. Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial. Diabetes Obes Metab. 2019 Jul;21(7):1642-1651. doi: 10.1111/dom.13702. Epub 2019 Apr 2.

Drugs

Indications