144 Participants Needed

Weight Loss for Obesity and Metabolic Syndrome

BH
Overseen ByBeth Henk
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

The community-based behavioral weight-loss treatment has shown to be safe, with participants experiencing sustained weight loss and improvements in health markers like cholesterol and insulin levels, without significant adverse effects.12345

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?

SK

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

I am obese but do not have diabetes, with a healthy liver and normal blood sugar levels.
I am lean, scheduled for specific surgery, with normal blood sugar and liver fat levels.
I am obese with a BMI of 35 or higher and scheduled for weight loss and gallbladder surgery.
See 2 more

Exclusion Criteria

I was diagnosed with cancer within the last 5 years.
I am not on any medications that could affect the study's outcome.
You have a history of drinking too much alcohol.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including insulin sensitivity, liver tissue inflammation, and adipose tissue inflammation are conducted

1 week

Weight Loss Intervention

Participants scheduled for bariatric surgery undergo weight loss intervention with assessments before and after 20-30% weight loss

3-4 months

Follow-up

Participants are monitored for changes in metabolic and immunologic markers post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Weight loss
Trial Overview The study investigates how the body stores fat in organs like the liver and its impact on health. The focus is on understanding obesity-related inflammation and cardiometabolic risk which could inform future treatments for diabetes and heart disease.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: Obese, scheduled for bariatric surgeryExperimental Treatment1 Intervention
Subjects with a body mass index ≥35.0 kg/m² undergoing bariatric surgery
Group II: Lean, metabolically normalActive Control1 Intervention
Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.
Group III: Obese, metabolically abnormalActive Control1 Intervention
Subjects with body mass index ≥30.0 kg/m² and impaired fasting or oral glucose tolerance and increased liver fat.
Group IV: Obese, metabolically normalActive Control1 Intervention
Subjects with body mass index ≥30.0 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.
Group V: Obese, scheduled for gallbladder surgeryActive Control1 Intervention
Subjects with a body mass index ≥35.0 kg/m² undergoing gallbladder surgery
Group VI: Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgeryActive Control1 Intervention
Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.

Weight loss is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Behavioral Weight Loss Program for:
  • Obesity
  • Weight Management
🇪🇺
Approved in European Union as Weight Management Program for:
  • Obesity
  • Overweight

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.
The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.
Weight Loss Strategies.Roberts, SB., Anton, S., Dao, MC.[2022]
Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.
Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity.Jones, LR., Wilson, CI., Wadden, TA.[2007]
Obesity is a significant public health issue that increases the risk of serious health conditions like type 2 diabetes, hypertension, and heart disease, highlighting the importance of effective weight management.
A successful weight loss program should be personalized and may include dietary changes, physical activity, behavior modification, and, for some patients, medications or surgery to ensure safety and efficacy.
Safe and effective management of the obese patient.Collazo-Clavell, ML.[2022]

Citations

Weight Loss Strategies. [2022]
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]
Management of Obesity. [2018]
Safe and effective management of the obese patient. [2022]
Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. [2015]
[Effects of health management programs on weight among overweight or obese adults]. [2018]
Evidence for success of caloric restriction in weight loss and control. Summary of data from industry. [2019]
Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]
Lifestyle medicine consulting walking meetings for sustained weight loss. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Two-year follow-up of an interdisciplinary cognitive-behavioral intervention program for obese adults. [2012]
11.United Statespubmed.ncbi.nlm.nih.gov
Behavioral management of obesity. [2019]
Personalized multistep cognitive behavioral therapy for obesity. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Association between weight-loss history and weight loss achieved in clinical obesity management: Retrospective chart review. [2022]
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