Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
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.
...
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)