The Possible Effects of Roflumilast on Obesity Related Disorders

NCT04800172 | Completed Phase 3

• 1 other identifier: 34538/3/21
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 HOMA-IR index

  HOMA-IR will be calculated for all patients at baseline and 3 months later.

  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 Outcomes (2)

• Changes in TNF-alfa serum level

  baseline and 3 months later

• Changes in malondialdehyde serum level (MDA)

  baseline and 3 months later

Study Arms (2)

Roflumilast arm

ACTIVE COMPARATOR

Drug: Roflumilast

Placebo arm

PLACEBO COMPARATOR

Drug: placebo

Interventions

Roflumilast DRUG

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

Roflumilast arm

placebo DRUG

administration of placebo tablet once daily for 3 months.

Placebo arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Sara Mohammad Zayed

Tanta, Egypt

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sara M Zayed

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: May 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)