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The Possible Effects of Roflumilast on Obesity Related Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04800172
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sara Mohammed Zayed, Tanta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity PreDiabetes Drug: Roflumilast Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: The Possible Effects of Roflumilast on Obesity Related Disorders
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Roflumilast arm Drug: Roflumilast
administration of roflumilast 500 mcg tablet once daily for 3 months.
Placebo Comparator: Placebo arm Drug: placebo
administration of placebo tablet once daily for 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. Change in patients body weight [ Time Frame: baseline and 3 months later ]
    substracting pre-treatment from post-treatment values.

  2. Change in blood glucose [ Time Frame: baseline and 3 months later ]
    using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.

  3. Change in plasma insulin level [ Time Frame: baseline and 3 months later ]
    substracting pre-treatment from post-treatment values of plasma insulin.

  4. Change in HOMA-IR index [ Time Frame: baseline and 3 months later ]
    HOMA-IR will be calculated for all patients at baseline and 3 months later.

  5. Change in blood lipid levels [ Time Frame: baseline and 3 months later ]
    blood lipid levels will be measured at baseline and 3 months after treatment including total cholesterol, triglycerides, HDL-C and LDL-C.


Secondary Outcome Measures :
  1. Changes in TNF-alfa serum level [ Time Frame: baseline and 3 months later ]
    substracting pre-treatment from post-treatment values of TNF-alfa.

  2. Changes in malondialdehyde serum level (MDA) [ Time Frame: baseline and 3 months later ]
    substracting pre-treatment from post-treatment values of MDA.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800172


Contacts
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Contact: Sara M Zayed 00201019724428 sonsonmg85@gmail.com

Locations
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Egypt
Sara Mohammad Zayed Recruiting
Tanta, Egypt
Contact: Sara M Zayed    00201019724428    sonsonmg85@gmail.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sara M Zayed Tanta University
More Information
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Responsible Party: Sara Mohammed Zayed, Pharm D, Tanta University
ClinicalTrials.gov Identifier: NCT04800172    
Other Study ID Numbers: 34538/3/21
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data of outcomes and other research but not personal data are intended to be published in application to scientific journals

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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
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight