Weight Loss for Obesity and Metabolic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn more about how the body stores fat in and around organs (for example in the liver) and why this affects some people's health more than others. Understanding this may lead to better treatments for diseases such as diabetes and cardiovascular disease.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that might affect the study results. It's best to discuss your specific medications with the trial team.
Is the Weight Loss for Obesity and Metabolic Syndrome treatment safe for humans?
How does the Weight Loss treatment for obesity and metabolic syndrome differ from other treatments?
The Weight Loss treatment, also known as a Behavioral Weight Loss Program, is unique because it combines lifestyle changes with cognitive-behavioral strategies to help individuals set goals, plan actions, and manage barriers, which supports long-term weight maintenance. Unlike some other treatments, it focuses on a comprehensive approach that includes diet, exercise, and psychological factors, making it more effective in maintaining weight loss over time.56789
What data supports the effectiveness of the treatment for weight loss in obesity and metabolic syndrome?
Research shows that lifestyle interventions, which include diet changes, physical activity, and behavior therapy, can lead to weight loss of 5-10% of initial weight. This amount of weight loss can improve health issues like type 2 diabetes and high blood pressure, making these interventions effective for managing obesity and related conditions.510111213
Who Is on the Research Team?
Samuel Klein, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with obesity, some of whom may be scheduled for bariatric or gallbladder surgery. Participants should have a BMI ≥30 kg/m2 and meet certain health criteria like normal blood sugar levels and liver fat content. It's not open to those with other liver diseases, alcohol abuse history, severe hypertriglyceridemia, recent cancer diagnosis, or who are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline measurements including insulin sensitivity, liver tissue inflammation, and adipose tissue inflammation are conducted
Weight Loss Intervention
Participants scheduled for bariatric surgery undergo weight loss intervention with assessments before and after 20-30% weight loss
Follow-up
Participants are monitored for changes in metabolic and immunologic markers post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Weight loss
Weight loss is already approved in United States, European Union for the following indications:
- Obesity
- Weight Management
- Obesity
- Overweight
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University