- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551193
Evaluating Weight Loss Outcomes in Patients With Overweight or Obesity
Study Overview
Status
Conditions
Detailed Description
The goal of this observational study is to learn how much weight adults with overweight or obesity lose after taking weight management for 12 months. The study also aims to learn whether these medications improve blood sugar and cholesterol levels, and how safe and tolerable they are.
The main questions it aims to answer are:
How much weight (in kilograms and percentage) do patients lose after 12 months of treatment? Do patients' fasting blood sugar, HbA1c, and cholesterol levels improve after 12 months? What side effects or treatment discontinuations occur in routine clinical practice? Researchers will compare weight loss outcomes among different patient groups based on age, sex, baseline BMI, and the specific medication used.
This is a retrospective study, meaning participants will not be asked to do anything new. Researchers will collect information from existing medical records and pharmacy claims at Aldafter Medical Center (ADMC) in Bahrain, including weight measurements, lab results, and medication histories from routine clinical care.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Manama, Bahrain
- AlDafter Medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: Adults aged 18 years or older.
- Body Mass Index (BMI): Patients classified as overweight (BMI 25-29.9 kg/m²) or obese (BMI ≥30 kg/m²).
- Medication: At least one pharmacy claim for any approved weight management medication
Continuous Enrollment: Patients must have continuous enrollment in medical and pharmacy insurance for 1 year prior to the index date (date of treatment initiation) and 1 year afterward.
-
Exclusion Criteria:
- Type 1 Diabetes: Patients with a diagnosis of type 1 diabetes.
- Non-Compliance: Evidence of non-compliance with treatment (e.g., gaps in therapy greater than 30 days).
- Bariatric Surgery: Patients who have undergone bariatric surgery in the past 5 years.
- Serious Comorbidities: Presence of serious medical conditions that may confound weight loss outcomes (e.g., uncontrolled psychiatric disorders, cancer).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute Weight Change
Time Frame: Baseline to 12 months
|
Absolute weight change (kg) from baseline to 12 months
|
Baseline to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMC-WL-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
National Taiwan University HospitalCompleted
-
PfizerRecruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasRecruitingPediatric Obesity | Pediatric Overweight | Overweight , ObesityUnited States
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal