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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast arm | Active Comparator |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | administration of roflumilast 500 mcg tablet once daily for 3 months. |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara M Zayed | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara Mohammad Zayed | Tanta | Egypt |
Data of outcomes and other research but not personal data are intended to be published in application to scientific journals
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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double-blind
| placebo |
| Drug |
administration of placebo tablet once daily for 3 months. |
|
| baseline and 3 months later |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |