Obesity; Endocrine; Diabetes Type 2Early Phase 1NCT04075110
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus
A Early Phase 1 study testing Montelukast 10mg in people with Obesity; Endocrine; Diabetes Type 2, run by Sadat City University at 1 site in Egypt.
Trial summary
The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity; Endocrine; Diabetes Type 2
- What is being tested?
- Montelukast 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 10 Apr 2023
- Phase
- Early Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.
Who cannot join
- patients who had any other inflammatory disease
- patients with cardiovascular,
- patients with asthma
- patients with severe hepatic
- patients with renal disease,
- patients with epilepsy
- pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).
- Conditions
- Obesity; Endocrine; Diabetes Type 2
- Being tested
- Montelukast 10mg, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10mgDrug
Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.
PlaceboDrug
Placebo tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 50 patients will receive metformin up to 2000mg/daily (Control group) Receives: Drug: Placebo |
| Montelukast group | Experimental | 50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day). Receives: Drug: Montelukast 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
HbA1c
Measured: From baseline to 12 weeks
Percent change in body weight
Body Weight
Measured: From baseline to 12 weeks
BMI
body mass index
Measured: From baseline to 12 weeks
Visceral Adiposity Index
visceral fat
Measured: From baseline to 12 weeks
Secondary outcomes (4)
Adiponectin
Serum level of adiponectin
Measured: At baseline to 12 weeks
TNF-α
Serum level of Tumor necrosis factor alpha (TNF-α)
Measured: At baseline to 12 weeks
IL-6
Serum level of interleukin-6 (IL-6)
Measured: At baseline to 12 weeks
leukotriene B4
Serum level of leukotriene B4 (LTB4)
Measured: At baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Jul 2019
- Primary completion1 Jun 2022
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity; Endocrine; Diabetes Type 2Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075110
- Sponsor's protocol ID
- 7-2021INTM1
- Status last verified
- Apr 2023
- First submitted
- 28 Aug 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
El-Khateeb E, El-Berri EI, Mosalam EM, Nooh MZ, Abdelsattar S, Alghamdi AM, Alrubia S, Abdallah MS. Evaluating the safety and efficacy of the leukotriene receptor antagonist montelukast as adjuvant therapy in obese patients with type 2 diabetes mellitus: A double-blind, randomized, placebo-controlled trial. Front Pharmacol. 2023 Apr 11;14:1153653. doi: 10.3389/fphar.2023.1153653. eCollection 2023.
PubMed 37113754
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04075110
- Acronym / sponsor ID
- 7-2021INTM1
- Conditions
- Obesity; Endocrine; Diabetes Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 30 Aug 2019 (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.
The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo50 patients will receive metformin up to 2000mg/daily (Control group) |
| Montelukast group | Experimental | Drug: Montelukast 10mg50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.
Key exclusion criteria (7 listed)
- patients who had any other inflammatory disease
- patients with cardiovascular,
- patients with asthma
- patients with severe hepatic
- patients with renal disease,
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 |
|---|---|---|
| Montelukast 10mgMontelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis. | Drug | Montelukast group |
| PlaceboPlacebo tablet once daily | Drug | Control group |
Primary outcome
Change in HbA1c
Time frame: From baseline to 12 weeks
HbA1c
Percent change in body weight
Time frame: From baseline to 12 weeks
Body Weight
BMI
Time frame: From baseline to 12 weeks
body mass index
Visceral Adiposity Index
Time frame: From baseline to 12 weeks
visceral fat
4 secondary outcomes
Adiponectin
Time frame: At baseline to 12 weeks
TNF-α
Time frame: At baseline to 12 weeks
IL-6
Time frame: At baseline to 12 weeks
leukotriene B4
Time frame: At baseline to 12 weeks
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 11 Apr 2023.
- Derived from this study: PubMed 37113754El-Khateeb E, El-Berri EI, Mosalam EM, Nooh MZ, Abdelsattar S, Alghamdi AM, Alrubia S, Abdallah MS. Evaluating the safety and efficacy of the leukotriene receptor antagonist montelukast as adjuvant therapy in obese patients with type 2 diabetes mellitus: A double-blind, randomized, placebo-controlled trial. Front Pharmacol. 2023 Apr 11;14:1153653. doi: 10.3389/fphar.2023.1153653. eCollection 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Montelukast 10mg in people with Obesity; Endocrine; Diabetes Type 2, run by Sadat City 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 1 inclusion and 7 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 11 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 HbA1c (time frame: From baseline to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075110, which also lists 1 linked publication.
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 11 Apr 2023.