Status:
COMPLETED
The Possible Effects of Roflumilast on Obesity Related Disorders
Lead Sponsor:
Tanta University
Conditions:
Obesity
PreDiabetes
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief Summary
Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.
Eligibility Criteria
Inclusion
- Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
- Obese subjects (BMI ≥30 kg/m2 and \<40 kg/m2).
Exclusion
- Patients with morbid obesity (BMI \> 40 kg/m2).
- Patients already on weight lowering agents or weight loss program.
- History or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant.
- Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
- Women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study.
- Patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity.
- Diabetic patients and patients with any inflammatory disease.
- Smokers.
- Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04800172
Start Date
May 1 2021
End Date
March 31 2022
Last Update
April 5 2022
Active Locations (1)
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1
Sara Mohammad Zayed
Tanta, Egypt