The Possible Effects of Roflumilast on Obesity Related Disorders

Phase 3

Completed

• Conditions: PreDiabetes; Obesity
• Interventions: Drug: placebo; Drug: Roflumilast

• Registration Number: NCT04800172
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Study Start: 2021-05-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
2. Obese subjects (BMI ≥30 kg/m2 and <40 kg/m2).

Exclusion Criteria

1. Patients with morbid obesity (BMI > 40 kg/m2).
2. Patients already on weight lowering agents or weight loss program.
3. 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.
4. Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
5. 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.
6. 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.
7. Diabetic patients and patients with any inflammatory disease.
8. Smokers.
9. Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	placebo	-
Roflumilast arm	Roflumilast	-

Primary Outcome Measures

Name	Time	Method
Change in blood glucose	baseline and 3 months later	using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.
Change in patients body weight	baseline and 3 months later	substracting pre-treatment from post-treatment values.
Change in plasma insulin level	baseline and 3 months later	substracting pre-treatment from post-treatment values of plasma insulin.
Change in HOMA-IR index	baseline and 3 months later	HOMA-IR will be calculated for all patients at baseline and 3 months later.
Change in blood lipid levels	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 Outcome Measures

Name	Time	Method
Changes in malondialdehyde serum level (MDA)	baseline and 3 months later	substracting pre-treatment from post-treatment values of MDA.
Changes in TNF-alfa serum level	baseline and 3 months later	substracting pre-treatment from post-treatment values of TNF-alfa.

Trial Locations

Locations (1)

Sara Mohammad Zayed; 🇪🇬 Tanta, Egypt