The Possible Effects of Roflumilast on Obesity Related Disorders

Obesity Clinical Trial

Official title:

The Possible Effects of Roflumilast on Obesity Related Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800172
• Other study ID #: 34538/3/21
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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 ß-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.)

Related Conditions & MeSH terms

• Obesity
• PreDiabetes

Intervention

Drug:
• Roflumilast
administration of roflumilast 500 mcg tablet once daily for 3 months.
• placebo
administration of placebo tablet once daily for 3 months.

Locations

Country	Name	City	State
Egypt	Sara Mohammad Zayed	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patients body weight	substracting pre-treatment from post-treatment values.	baseline and 3 months later
Primary	Change in blood glucose	using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.	baseline and 3 months later
Primary	Change in plasma insulin level	substracting pre-treatment from post-treatment values of plasma insulin.	baseline and 3 months later
Primary	Change in HOMA-IR index	HOMA-IR will be calculated for all patients at baseline and 3 months later.	baseline and 3 months later
Primary	Change in blood lipid levels	blood lipid levels will be measured at baseline and 3 months after treatment including total cholesterol, triglycerides, HDL-C and LDL-C.	baseline and 3 months later
Secondary	Changes in TNF-alfa serum level	substracting pre-treatment from post-treatment values of TNF-alfa.	baseline and 3 months later
Secondary	Changes in malondialdehyde serum level (MDA)	substracting pre-treatment from post-treatment values of MDA.	baseline and 3 months later