Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals
- Roflumilast is a drug used to treat chronic obstructive pulmonary disease (COPD). It is designed to help reduce lung inflammation. However, during testing, roflumilast also appeared to reduce high blood sugar levels in people with COPD and type 2 diabetes. Other tests showed that roflumilast also improved blood sugar levels in people who only had type 2 diabetes. Researchers want to see how roflumilast affects insulin and blood sugar levels in overweight or obese people who are not diabetic, but who have high blood sugar levels.
- To see how well roflumilast improves blood sugar and insulin levels in prediabetic overweight or obese individuals.
- Individuals between 30 to 65 years old who are overweight or obese (body mass index of 24.9 to 39.9 kg/m2) and have elevated blood sugar levels.
- This study will last approximately 8 weeks. Participants will have approximately five study visits over about 7 weeks. Two of these visits will be overnight inpatient stays.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have a 3-day diet and exercise assessment with a dietitian.
- In Week 1, participants will have a special diet for 2 days to keep their regular weight. They will then have a 2-day inpatient stay. During their stay, they will have multiple tests, including blood sugar tests and full body scans. They may provide a fat and muscle tissue biopsy sample. They will then receive the study drug to take during the study.
- In Week 2, participants will repeat the diet study from the screening visit. They will receive a different dose of the study drug.
- In Week 3, participants will review their diet results and have blood and urine tests.
- In Week 5, participants will repeat the diet and exercise study from the screening visit.
- In Week 6, participants will repeat the inpatient studies and tests from Week 1.
In the last week, participants will have a final follow-up visit.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Study to Evaluate the Effects of Roflumilast on Insulin Sensitivity and Metabolic Parameters in Prediabetic Overweight and Obese Individuals|
- The primary outcome in this study is changes in insulin sensitivity as measured by the stable isotope0-labeled tracer technique and glucose clamp. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
- The secondary outcomes are changed in beta-cell function, postprandial plasma incretin concentrations, circulating levels of adipokines, cytokines, and inflammatory markers, and alterrations in total body fat and lean body mass. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Selective phosphodiesterase 4 (PDE4) inhibitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862029
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jay H Chung, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|