The Possible Effects of Roflumilast on Obesity Related Disorders

Study Overview
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Brief Summary
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Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.

Official Title
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The Possible Effects of Roflumilast on Obesity Related Disorders

Conditions
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Obesity, PreDiabetes

Intervention / Treatment
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* Drug: Roflumilast
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roflumilast arm<br> | Drug: Roflumilast<br>* administration of roflumilast 500 mcg tablet once daily for 3 months.<br>|
| Placebo Comparator: Placebo arm<br> | Drug: placebo<br>* administration of placebo tablet once daily for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patients body weight | substracting pre-treatment from post-treatment values. | baseline and 3 months later | 
| Change in blood glucose | using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values. | baseline and 3 months later | 
| Change in plasma insulin level | substracting pre-treatment from post-treatment values of plasma insulin. | baseline and 3 months later | 
| Change in HOMA-IR index | HOMA-IR will be calculated for all patients at baseline and 3 months later. | baseline and 3 months later | 
| Change in blood lipid levels | blood lipid levels will be measured at baseline and 3 months after treatment including total cholesterol, triglycerides, HDL-C and LDL-C. | baseline and 3 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in TNF-alfa serum level | substracting pre-treatment from post-treatment values of TNF-alfa. | baseline and 3 months later | 
| Changes in malondialdehyde serum level (MDA) | substracting pre-treatment from post-treatment values of MDA. | baseline and 3 months later |