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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
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

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin sensitivity
Secondary outcome measures
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

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
1,933 Previous Clinical Trials
2,299,581 Total Patients Enrolled
77 Trials studying Obesity
13,673 Patients Enrolled for Obesity
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,742 Total Patients Enrolled
40 Trials studying Obesity
116,818 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants younger than 30 years old?

"The trial only allows participants between the ages of 18 and 90 to enroll. In contrast, there are 258 studies available for those below the age of majority and 1223 trials accessible to people above 65 years old."

Answered by AI

What is the size of this medical experiment's sample population?

"Indeed, clinicaltrials.gov confirms that this medical experiment is currently enrolling patients. The trial was initially posted on April 1st 2010 and most recently updated on December 6th 2022; it requires 144 participants from a single site to complete the study."

Answered by AI

Are there any available slots for subjects to join this research trial?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical study, initially posted on April 1st 2010, is currently recruiting patients. One medical centre will be enrolling a total of 144 individuals in the trial."

Answered by AI

Does my background qualify me for participation in this clinical research?

"This research seeks 144 individuals with obesity, aged between 18 and 90 years old. To qualify for the study, patients must have a body mass index of at least 35kg/m2 and be due to undergo bariatric or gallbladder surgery."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Up and down the scale all my life. Looking for a perm. weight loss solution.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Washington University School of Medicine: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
ctgfJournal
Adipose Tissue <i>ctgf</i> Expression Is Associated with Adiposity and Insulin Resistance in Humans
Yoshino, Jun, Bruce W. Patterson, and Samuel Klein. 2019. “Adipose Tissue ctgf Expression Is Associated with Adiposity and Insulin Resistance in Humans”. Obesity. Wiley. doi:10.1002/oby.22463.
clinicaltrials.govStudy
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
2010. "Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01104220.
All > Nonalcoholic Fatty Liver Disease > Missouri
~3 spots leftby Sep 2024
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