CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Pioglitazone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02338999
NCT02338999Phase 2Completed

The Role of PPAR-Gamma Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·interventional·Posted Jan 15, 2015·Updated Sep 14, 2021

In Brief

A Phase 2 clinical trial evaluating PET/CT, Pioglitazone, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 15, 2015
Enrollment StartJun 18, 2015
Primary CompletionJul 14, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.5 years ago

Interventions

PET/CTradiation

The combined PET/CT scans provide images that pinpoint the anatomic location of abnormal metabolic activity within the body.

Pioglitazonedrug

Increases insulin sensitivity in muscle and adipose tissue, and inhibits hepatic gluconeogenesis.

Placebodrug