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OpenTrials
Completed

NCT Number: NCT04800172

The Possible Effects of Roflumilast on Obesity Related Disorders

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Roflumilast

Drug

administration of roflumilast 500 mcg tablet once daily for 3 months.

Placebo

Drug

administration of placebo tablet once daily for 3 months.

Primary outcomes

  1. Change in patients body weight

    Time frame: baseline and 3 months later

    substracting pre-treatment from post-treatment values.

  2. Change in blood glucose

    Time frame: baseline and 3 months later

    using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.

  3. Change in plasma insulin level

    Time frame: baseline and 3 months later

    substracting pre-treatment from post-treatment values of plasma insulin.

  4. Change in HOMA-IR index

    Time frame: baseline and 3 months later

    HOMA-IR will be calculated for all patients at baseline and 3 months later.

  5. Change in blood lipid levels

    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.

Secondary outcomes

  1. Changes in TNF-alfa serum level

    Time frame: baseline and 3 months later

    substracting pre-treatment from post-treatment values of TNF-alfa.

  2. Changes in malondialdehyde serum level (MDA)

    Time frame: baseline and 3 months later

    substracting pre-treatment from post-treatment values of MDA.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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