Obesity, PreDiabetes
Conditions
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.
Interventions
DRUGRoflumilast
administration of roflumilast 500 mcg tablet once daily for 3 months.
DRUGplacebo
administration of placebo tablet once daily for 3 months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%). 2. Obese subjects (BMI ≥30 kg/m2 and \<40 kg/m2).
Exclusion criteria
1. Patients with morbid obesity (BMI \> 40 kg/m2). 2. Patients already on weight lowering agents or weight loss program. 3. 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. 4. Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy. 5. 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. 6. 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. 7. Diabetic patients and patients with any inflammatory disease. 8. Smokers. 9. Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood glucose | baseline and 3 months later | using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values. |
| Change in HOMA-IR index | baseline and 3 months later | HOMA-IR will be calculated for all patients at baseline and 3 months later. |
| Change in blood lipid levels | baseline and 3 months later | blood lipid levels will be measured at baseline and 3 months after treatment including total cholesterol, triglycerides, HDL-C and LDL-C. |
| Change in patients body weight | baseline and 3 months later | substracting pre-treatment from post-treatment values. |
| Change in plasma insulin level | baseline and 3 months later | substracting pre-treatment from post-treatment values of plasma insulin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in malondialdehyde serum level (MDA) | baseline and 3 months later | substracting pre-treatment from post-treatment values of MDA. |
| Changes in TNF-alfa serum level | baseline and 3 months later | substracting pre-treatment from post-treatment values of TNF-alfa. |
Countries
Egypt
Outcome results
None listed