Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
administration of roflumilast 500 mcg tablet once daily for 3 months.
administration of placebo tablet once daily for 3 months.
Sara Mohammad Zayed
Tanta, Egypt
Change in patients body weight
substracting pre-treatment from post-treatment values.
Time frame: 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.
Time frame: baseline and 3 months later
Change in plasma insulin level
substracting pre-treatment from post-treatment values of plasma insulin.
Time frame: baseline and 3 months later
Change in HOMA-IR index
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Time frame: 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.
Time frame: baseline and 3 months later
Changes in TNF-alfa serum level
substracting pre-treatment from post-treatment values of TNF-alfa.
Time frame: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
substracting pre-treatment from post-treatment values of MDA.
Time frame: baseline and 3 months later
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