ObesityPhase 3NCT04800172
The Possible Effects of Roflumilast on Obesity Related Disorders
A Phase 3 study testing Roflumilast in people with Obesity and PreDiabetes, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity, PreDiabetes
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 31 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Diabetic patients and patients with any inflammatory disease.
- Smokers.
- Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Roflumilast, placebo
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
administration of roflumilast 500 mcg tablet once daily for 3 months.
placeboDrug
administration of placebo tablet once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast arm | Active comparator | Not described Receives: Drug: Roflumilast |
| Placebo arm | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients body weight
substracting pre-treatment from post-treatment values.
Measured: 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.
Measured: baseline and 3 months later
Change in plasma insulin level
substracting pre-treatment from post-treatment values of plasma insulin.
Measured: baseline and 3 months later
Change in HOMA-IR index
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Measured: 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.
Measured: baseline and 3 months later
Secondary outcomes (2)
Changes in TNF-alfa serum level
substracting pre-treatment from post-treatment values of TNF-alfa.
Measured: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
substracting pre-treatment from post-treatment values of MDA.
Measured: baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 May 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Zayed, Tanta University
- Investigators
- Sara M Zayed, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800172
- Sponsor's protocol ID
- 34538/3/21
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of outcomes and other research but not personal data are intended to be published in application to scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Effects of Roflumilast on Obesity Related Disorders
- ClinicalTrials.gov ID
- NCT04800172
- Acronym / sponsor ID
- 34538/3/21
- Conditions
- Obesity, PreDiabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast arm | Active comparator | Drug: Roflumilast |
| Placebo arm | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilastadministration of roflumilast 500 mcg tablet once daily for 3 months. | Drug | Roflumilast arm |
| placeboadministration of placebo tablet once daily for 3 months. | Drug | Placebo arm |
Primary outcome
Change in patients body weight
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values.
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.
Change in plasma insulin level
Time frame: baseline and 3 months later
substracting pre-treatment from post-treatment values of plasma insulin.
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.
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.
2 secondary outcomes
Changes in TNF-alfa serum level
Time frame: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
Time frame: baseline and 3 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No. Data of outcomes and other research but not personal data are intended to be published in application to scientific journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara M Zayed principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast in people with Obesity and PreDiabetes, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients body weight (time frame: baseline and 3 months later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.