Weight Loss for Obesity and Metabolic Syndrome

Not currently recruiting at 1 trial location

Overseen By Beth Henk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Confounding medications

Disqualifiers: Liver diseases, Alcohol abuse, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how fat stored around organs, like the liver, impacts health, potentially leading to better treatments for conditions like diabetes and heart disease. It explores different groups: lean individuals, those who are obese and healthy, and those who are obese with metabolic issues. The study also includes people who are obese and planning to have bariatric or gallbladder surgery. Suitable participants include those who are obese with signs of metabolic problems, such as high blood sugar or liver fat, or those already scheduled for certain surgeries. The primary treatment under study is a Behavioral Weight Loss Program, which focuses on lifestyle interventions to manage weight. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to innovative treatments for metabolic health issues.

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.

What prior data suggests that this weight loss program is safe?

Research has shown that bariatric surgery is generally safe for those who qualify. One study found the risk of dying from the surgery is very low, about 0.1%. Major complications occur in about 4% of cases, meaning 96% of patients do not experience significant issues.

Furthermore, bariatric surgery has been proven to aid in weight loss and reduce the risk of obesity-related health problems, such as diabetes and heart disease. Many patients maintain significant weight loss for years after the surgery.

These findings suggest that while some risks exist, bariatric surgery is mostly well-tolerated and can benefit many people struggling with obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different profiles of obesity and metabolic health, aiming to uncover tailored strategies for weight loss and metabolic syndrome management. Unlike traditional blanket approaches, this trial examines varied groups, including those undergoing bariatric surgery, to determine how different metabolic states influence outcomes. This could lead to more personalized and effective interventions, moving beyond the standard diet and exercise recommendations to address the underlying metabolic differences among individuals. By focusing on unique subgroups, this trial hopes to identify more precise, targeted treatments that cater to the specific needs of different patients.

What evidence suggests that this trial's treatments could be effective for obesity and metabolic syndrome?

Research has shown that bariatric surgery, one of the treatments studied in this trial, effectively aids in weight loss and improves obesity-related health issues. Many patients lose a significant amount of weight and maintain it for several years. Specifically, about 44% of patients lose 20% of their total weight two years post-surgery, and about 32% maintain this weight loss after five years. Additionally, bariatric surgery significantly reduces the risk of serious health problems like diabetes and heart disease. Long-term studies indicate that weight loss from surgery remains stable for over ten years. This strong evidence supports its effectiveness in treating obesity and related health conditions. ^{1 2 3 5 6}

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

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.

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.

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?

Group I: Obese, scheduled for bariatric surgery Experimental Treatment 1 Intervention

Subjects with a body mass index ≥35.0 kg/m² undergoing bariatric surgery

Group II: Lean, metabolically normal Active Control 1 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 abnormal Active Control 1 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 normal Active Control 1 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 surgery Active Control 1 Intervention

Subjects with a body mass index ≥35.0 kg/m² undergoing gallbladder surgery

Group VI: Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery Active Control 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

Comprehensive behavioral weight loss programs have evolved to include systematic work on various factors such as eating behavior, exercise, attitudes, and social relationships, leading to significant weight losses of 25 to 30 pounds.

The most notable strength of these behavioral programs is their effectiveness in maintaining weight loss over time, which is crucial for long-term success in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of obesity. Brownell, KD., Kramer, FM.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

In a pilot study involving 45 obese patients with coronary heart disease, those who participated in a commercial weight management program (Weight Watchers) achieved a significant average weight loss of 5.8 kg, with 91% of participants losing weight.

After 14 weeks, 27 patients continued the program and experienced an even greater average weight loss of 9.1 kg, indicating that the program can be effective for long-term weight management in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. Minneboo, M., Peters, RJ., Miller-Kovach, K., et al.[2015]

A randomized controlled trial involving 88 patients with morbid obesity demonstrated that multistep cognitive behavioral therapy for obesity (CBT-OB) led to a significant mean weight loss of 15% after 12 months, with no weight regain observed between months 6 and 12.

CBT-OB has shown promising long-term results for managing obesity related to binge-eating disorder, and ongoing outpatient studies may further validate its effectiveness compared to standard weight-loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized multistep cognitive behavioral therapy for obesity. Dalle Grave, R., Sartirana, M., El Ghoch, M., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. Collazo-Clavell, ML.[2022]

A community-based weight-loss treatment program involving 90 participants led to significant weight loss and sustained health improvements, including reductions in waist circumference and cholesterol levels, over an 18-month period.

Participants maintained their weight loss without significant regain at follow-ups, demonstrating the effectiveness of the program in promoting long-term behavioral and psychological benefits for overweight and obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. Latner, JD., Ciao, AC., Wendicke, AU., et al.[2013]

In a study involving 738 overweight or obese participants, those in a health management program lost significantly more weight (2.19 kg) and body fat compared to those in a general management group (0.97 kg) after 6 months, indicating the effectiveness of structured health management for weight loss.

The health management program resulted in a higher effective weight loss rate of 24.2% and a body fat loss rate of 52.5%, compared to 11.8% and 34.3% in the general management group, demonstrating its potential as a safe and effective intervention for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of health management programs on weight among overweight or obese adults]. Wang, Z., Yang, Y., Fu, L., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353499/

Long-term effectiveness, outcomes and complications of ... This review aims to synthesize and summarize the growing evidence on the long-term effectiveness, outcomes and complications of bariatric surgery.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838651

Bariatric Surgery and Obesity-Related Comorbidities In this cohort study, patients who underwent bariatric surgery showed a significantly decreased risk of developing major metabolic comorbidities ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002961024007037

Weight loss outcomes and associated factors after ... At 2-years post-surgery, 43.6 ​% achieved ≥50 %EWL, and 44.1 ​% achieved ≥20%TWL, with 31.8 ​% maintaining this at 5-years. Depending on the definition used, ...

4. asmbs.org asmbs.org/resources/metabolic-and-bariatric-surgery/

Resource Categories Studies show patients typically lose the most weight 1-2 years after bariatric surgery and see substantial weight improvements in obesity-related conditions.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1700459

Weight and Metabolic Outcomes 12 Years after Gastric ... The mean percent weight loss in the surgery group remained stable between 6 years (28.0% weight loss) and 12 years (26.9%). Furthermore, at 12 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834364/

2022 American Society of Metabolic and Bariatric Surgery ... Overall weight loss outcomes for MBS that are durable for years after surgery are consistently reported at greater than 60% percent excess weight loss (%EWL), ...