The Possible Effects of Roflumilast on Obesity Related Disorders

Tanta University

Status and phase: Completed; Phase 3

Conditions: Obesity; PreDiabetes

Treatments: Drug: Roflumilast; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04800172

34538/3/21

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 2 patient groups, including a placebo group

Roflumilast arm

Active Comparator group

Treatment:

Drug: Roflumilast

Placebo arm

Placebo Comparator group

Treatment:

Drug: placebo