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Weight Loss for Obesity and Metabolic Syndrome

N/A
Waitlist Available
Led By Samuel Klein, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese, metabolically healthy group - BMI ≥30 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%
Obese, scheduled for bariatric and gallbladder surgery - BMI ≥35.0kg/m2
Must not have
Active or previous history of liver diseases other than NAFLD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating how fat is stored in organs, and why this impacts some people's health more than others. The findings could lead to better treatments for diabetes and cardiovascular disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves weight loss as an intervention rather than medication or medical procedures, side effects might include typical dieting symptoms such as fatigue, hunger pangs, mood swings, muscle cramps from exercise if applicable but no specific medicinal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am obese but do not have diabetes, with a healthy liver and normal blood sugar levels.
Select...
I am obese with a BMI of 35 or higher and scheduled for weight loss and gallbladder surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had liver diseases other than non-alcoholic fatty liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin sensitivity
Secondary study objectives
Abdominal adipose tissue inflammation
Change in exosome-mediated intercellular signaling
Exosome-mediated intercellular signaling
+5 more

Side effects data

From 2016 Phase 3 trial • 150 Patients • NCT00856609
98%
hunger decrease
60%
Nausea
57%
Headache
40%
Diarrhea
35%
Constipation
33%
Injection site reaction
33%
Gastroesophageal reflux
30%
Itchiness
28%
Vomiting
25%
hypoglycemia
15%
Skin rash
10%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Exenatide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,995 Previous Clinical Trials
2,296,577 Total Patients Enrolled
83 Trials studying Obesity
14,518 Patients Enrolled for Obesity
PfizerIndustry Sponsor
4,669 Previous Clinical Trials
17,861,698 Total Patients Enrolled
43 Trials studying Obesity
117,181 Patients Enrolled for Obesity
Samuel Klein, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
157 Total Patients Enrolled
2 Trials studying Obesity
67 Patients Enrolled for Obesity

Media Library

Obesity Clinical Trial 2023: Weight loss Highlights & Side Effects. Trial Name: NCT01104220 — N/A
~9 spots leftby Dec 2025
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