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.

Study Overview

• Status: Completed
• Conditions: Obesity; PreDiabetes
• Intervention / Treatment: Drug: Roflumilast; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Sara Mohammad Zayed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo arm	Drug: placebo; administration of placebo tablet once daily for 3 months.
ACTIVE_COMPARATOR: Roflumilast arm	Drug: Roflumilast; administration of roflumilast 500 mcg tablet once daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HOMA-IR index	HOMA-IR will be calculated for all patients at baseline and 3 months later.	baseline and 3 months later
Change in patients body weight	substracting pre-treatment from post-treatment values.	baseline and 3 months later
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
Change in plasma insulin level	substracting pre-treatment from post-treatment values of plasma insulin.	baseline and 3 months later
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sara M Zayed, Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (ACTUAL): March 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 34538/3/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data of outcomes and other research but not personal data are intended to be published in application to scientific journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No