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Procedure

Weight Loss Surgery for Obesity

N/A
Recruiting
Led By Michael D Jensen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery
No active physical illness that would interfere with mobility or weight loss after bariatric surgery
Must not have
Active coronary artery disease
Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effects of weight loss surgery on inflammation and lipolysis regulation.

Who is the study for?
This trial is for adults with severe obesity (BMI 40-50) who haven't been exercising regularly or taking certain medications that affect fat metabolism. It's not for those with active physical illnesses, liver disease, diabetes, kidney issues, heart disease, smokers, or pregnant/breastfeeding individuals.
What is being tested?
The study investigates how well bariatric surgery (sleeve gastrectomy) helps people lose a lot of weight and improves the way their bodies use insulin to break down fats. Researchers will compare inflammation and fat breakdown before and after surgery.
What are the potential side effects?
Potential side effects from gastric sleeve surgery can include pain at the incision site, nausea, vomiting, acid reflux, nutritional deficiencies due to reduced food intake capacity and changes in digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have any illnesses that would stop me from moving around or losing weight after weight-loss surgery.
Select...
I don't have any illnesses that would stop me from moving around or losing weight after weight-loss surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active heart artery disease.
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I have diabetes or my blood sugar level is high.
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My liver is not functioning well (high bilirubin or liver enzymes).
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My kidney function is reduced with a creatinine level over 1.5mg/dl.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
adipose macrophage content, adipose IL-6 and TNF gene expression
insulin regulation of lipolysis (IC50)
Secondary study objectives
adipocyte perilipin 1 and HSL and ATGL
Other study objectives
Long-term, substantial weight loss and insulin regulation of lipolysis

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gastric sleeve surgeryExperimental Treatment1 Intervention
before and after weight loss from bariatric surgery

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,931 Total Patients Enrolled
88 Trials studying Obesity
9,134 Patients Enrolled for Obesity
Michael D Jensen, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
116 Total Patients Enrolled
1 Trials studying Obesity
48 Patients Enrolled for Obesity

Media Library

Gastric Sleeve/Bariatric Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03868592 — N/A
Obesity Research Study Groups: Gastric sleeve surgery
Obesity Clinical Trial 2023: Gastric Sleeve/Bariatric Surgery Highlights & Side Effects. Trial Name: NCT03868592 — N/A
Gastric Sleeve/Bariatric Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868592 — N/A
~2 spots leftby May 2025
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