Status:
COMPLETED
Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- 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...
Detailed Description
Resveratrol, a polyphenol most notably found in red wine has anti-aging properties in mice fed a high-fat diet; resveratrol protects against obesity and type 2 diabetes. Several clinical trials have b...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adult, weight- and diet-stable men and women in good general health with no significant underlying illnesses and normal or clinically insignificant results (medical histories, laboratory profiles, physical examination, and electrocardiograms),
- Women must be non-pregnant or post-menopausal, or women of childbearing potential must be non-lactating and using an effective form of birth control during and for 30 days after the study period (partner's use of condoms or partner's vasectomy is not an acceptable contraception method for this study),
- Must be 30 - 65 years of age, inclusive
- Body Mass Index (BMI) \> 24.9 and \< 39.5 kg/m(2) with a stable (plus-minus 2.5 kg) weight for the last 6 months by history,
- Pre-diabetes, as defined by a fasting blood glucose of greater than 100 mg/dL and less than 126 mg/dL and/or A1C equal or greater than 5.7 and less than or equal to 6.5 %
- Subjects must be able to understand the protocol and provide written informed consent.
- EXCLUSION CRITERIA:
- Women will be excluded from our study if they are pregnant, breastfeeding, or if they plan to become pregnant prior to the end of the study,
- Cannot be on any medications including multivitamins or nutritional supplements that in the investigator s opinion will affect insulin sensitivity
- Currently taking systemic corticosteroids, insulin, or anticoagulants, anxiolytics, ketoconazole, erythromycin, cimetidine, enoxacin, strong CYP 3A4/1A2 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin), birth control pills containing gestodene and ethinyl estradiol, use food supplements that cannot be discontinued, or any other medication that the investigators deem a contraindication.
- AST or ALT \> 3 times the upper normal limit
- Hepatitis B antigen, HIV or C positive antibody tests,
- Liver disease, pulmonary disease, renal insufficiency, , (serum creatinine \> 1.5mg/dl), coronary heart disease, heart failure (New York Heart Association heart failure Class III or IV), peripheral vascular disease, coagulopathy.
- History of or current diagnosis of major depressive disorder, or history of or current diagnosis of other psychiatric disorders that in the opinion of the investigator would make participant unsafe for the participant.
- Currently being treated for any form of cancer or have a history of cancer, that in the investigator s judgment would not make the participant a candidate for the study for safety or scientific reasons.
- Claustrophobic,
- On a weight loss program with ongoing weight loss, or a history of eating disorders. Actively using tobacco products or have used tobacco products within last year (\>3 cigarettes/day), regular alcoholic beverage intake of more than two drinks per day. Subjects with any condition that would have made them, in the opinion of the principal investigator (PI), unsuitable for the study.
- Subjects with a contraindication for the ultrasound contrast agent.
Exclusion
Key Trial Info
Start Date :
May 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01862029
Start Date
May 22 2013
End Date
July 25 2017
Last Update
September 4 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892