Sara Mohammad Zayed
Tanta, Egypt
NCT Number: NCT04800172
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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Notify Me25 year–65 year
All sexes
Interventional
Phase 3
Tanta, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
administration of roflumilast 500 mcg tablet once daily for 3 months.
administration of placebo tablet once daily for 3 months.
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values.
Time frame: baseline and 3 months later
using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values of plasma insulin.
Time frame: baseline and 3 months later
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Time frame: 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.
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values of TNF-alfa.
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values of MDA.
Tanta University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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