Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-08-15
2026-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multidisciplinary program
Multidisciplinary weight loss program
Multidisciplinary weight loss program
Diet and behavioral therapy,and supervised exercise sessions
Metformin Hcl 850Mg Tab
1 tablet, twice daily
Control
Standard care
Standard Care
General lifestyle tips
Metformin Hcl 850Mg Tab
1 tablet, twice daily
Interventions
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Multidisciplinary weight loss program
Diet and behavioral therapy,and supervised exercise sessions
Standard Care
General lifestyle tips
Metformin Hcl 850Mg Tab
1 tablet, twice daily
Eligibility Criteria
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Inclusion Criteria
* Patients who can commit to frequent visit trials as per study protocol
* Patients not traveling outside Lebanon for at least the 6-month period of the trial
* Patients tolerating Metformin after a run-in period of 2 weeks
Exclusion Criteria
* Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at \< 6 months)
* Patients with diabetes
* Patients working at AUB-MC, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to AUB-MC only for clinical care
* A family member of a patient already enrolled in the study, as the participants will not be independent
* Pregnant obese patients
* Patients with pacemakers
* Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses
* History of any surgery of less than 6 weeks duration
* Patients known to have disabling osteoarthritic or orthopedic problems
* Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).
18 Years
ALL
Yes
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Marlene Chakhtoura
Assistant Professor of Medicine
Locations
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American University of Beirut - Medical Center
Beirut, Riad El Solh, Lebanon
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BIO-2018-0400
Identifier Type: -
Identifier Source: org_study_id
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