Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome
Status:
Completed
Trial end date:
2018-08-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)