Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
Status:
Completed
Trial end date:
2020-07-14
Target enrollment:
Participant gender:
Summary
Background:
- Lupus causes a person s immune system to attack the body. It can cause blood vessel
problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may help.
Objectives:
- To see how well pioglitazone improves blood vessel function and decreases blood vessel
inflammation. To study its effect on lupus symptoms.
Eligibility:
- Adults at least 18 years old with lupus.
Design:
- Participants will be screened with medical history, heart test, and blood and urine
tests. They may have a bone density test.
- Visit 1:
- Participants will have:
- Physical exam and blood drawn.
- Peripheral Arterial Tonometry (Endopat). A cup will be placed on the finger and a
pressure cuff on the arm.
- Cardio-ankle vascular index (CAVI) and/or Sphygmocor. Electrodes will be placed on both
wrists, a microphone on the chest, and a blood pressure cuff on each arm and leg.
Another test will involve placing a small device on a fingertip.
- 18-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography
(PET/CT) (some participants). A radioactive sugar will be injected into a small plastic
tube in an arm vein. Participants will lie on a bed that moves in and out of a scanner
that takes pictures.
- Participants will get a 3-month-supply of the study drug or placebo. After 1 week, their
dose may increase.
- After those 3 months, they will not take either drug for 8 weeks. Then they will switch
and take the other drug for 3 months.
- Participants will have 6 more visits over 8 months after Visit 1. Tests from Visit 1 may
be repeated. They may have a urine test.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)