Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02338999|
Recruitment Status : Recruiting
First Posted : January 15, 2015
Last Update Posted : May 20, 2019
- 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.
- To see how well pioglitazone improves blood vessel function and decreases blood vessel inflammation. To study its effect on lupus symptoms.
- Adults at least 18 years old with lupus.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erthematosus||Radiation: PET/CT Drug: Pioglitazone Procedure: Vascular function studies||Phase 1 Phase 2|
Systemic lupus erythematosus (SLE) is an autoimmune disease of unclear cause that affects primarily women of childbearing age. Patients with lupus have a significantly increased risk of developing complications of their blood vessels due to accelerated hardening of the arteries (atherosclerosis). These complications include heart attacks and stroke. No drug to date has proven to prevent this type of complication in lupus and premature vascular disease significantly impacts the quality of life of these patients and enhances their risk of death.
The thiazolidinediones (TZD) are a class of drugs approved for the treatment of patients with type 2 diabetes mellitus (DM); they belong to the family of drugs that activate the peroxisome proliferator-activated receptor-gamma (PPAR-gamma). They have been proposed to have strong anti-atherogenic and anti-inflammatory effects even in patients without diabetes. Recent work from our group and others indicates that TZDs significantly improve vascular damage, dysfunction of blood vessels and disease activity in mouse models of lupus and abrogate atherosclerosis. We recently identified the TZD pioglitazone as an effective drug in modulation of vascular function and disease activity in patients with rheumatoid arthritis. In addition, we have found in mouse models of lupus and in in vitro experiments with human lupus cells, that pioglitazone has important roles in modulating immune function and vascular manifestations. Furthermore, this drug is not immunosuppressive, adding an additional advantage when compared to other medications used in this disease.
We propose that TZDs could significantly improve blood vessel function and play a role in atherosclerosis prevention in human SLE, in addition to modifying lupus disease activity. The major goal of the proposed research is to assess the effects of the PPAR-gamma agonist pioglitazone in SLE on vascular function and inflammation and on SLE disease activity. The results of the study may lead to the characterization of a new therapeutic target with dual effects on lupus and its associated blood vessel damage
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Role of PPAR-Gamma Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)|
|Study Start Date :||January 14, 2015|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||June 18, 2020|
- Radiation: PET/CT
The combined PET/CT scans provide
- Drug: Pioglitazone
Increases insulin sensitivity in muscle.
- Procedure: Vascular function studies
- Vascular function and inflammation [ Time Frame: 3,5,8 months ]
- Lupus disease activity and immmunomodulation [ Time Frame: 3,5,8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338999
|Contact: Yenealem Temesgen-Oyelakin, R.N.||(301) email@example.com|
|Contact: Mariana J Kaplan, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Mariana J Kaplan, M.D.||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|