The Possible Effects of Roflumilast on Obesity Related Disorders

NCT ID: NCT04800172

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-03-31

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.

Conditions

Obesity; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Roflumilast arm

Group Type: ACTIVE_COMPARATOR

Roflumilast

Intervention Type: DRUG

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

Placebo arm

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

administration of placebo tablet once daily for 3 months.

Interventions

Roflumilast

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

Intervention Type: DRUG

placebo

administration of placebo tablet once daily for 3 months.

Intervention Type: DRUG

Eligibility Criteria

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.)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohammed Zayed

Pharm D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara M Zayed

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Sara Mohammad Zayed

Tanta, , Egypt

Countries

Egypt

Other Identifiers

34538/3/21

Identifier Type: -

Identifier Source: org_study_id