Weight Loss for Obesity and Metabolic Syndrome

Recruiting in Palo Alto (17 mi)

Overseen bySamuel Klein, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

Research Team

Samuel Klein, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

Treatment Details

Interventions

Weight loss (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.