Effects of weight loss on insulin regulation after bariatric surgery
Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
This study tests if losing a lot of weight after bariatric surgery helps people with severe obesity improve their insulin function and reduce inflammation over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03868592 on ClinicalTrials.gov |
What this trial studies
This study investigates how substantial weight loss through bariatric surgery, specifically sleeve gastrectomy, affects insulin regulation of lipolysis in individuals with Class III obesity. Researchers will analyze the relationship between adipose inflammatory cells, cytokine content, and insulin resistance before and after the surgery. The goal is to determine if sustained weight loss leads to reduced inflammation and improved insulin function over a one-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a BMI between 40 and 50 kg/m2 who do not have active physical illnesses that would interfere with mobility or weight loss.
Not a fit: Patients with Type 1 or Type 2 diabetes, active coronary artery disease, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how weight loss can improve insulin regulation and potentially reduce obesity-related complications.
How similar studies have performed: Other studies have shown promising results regarding the effects of bariatric surgery on insulin regulation and weight loss, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI 40 - 50 kg/m2. * Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery Exclusion Criteria: * Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL * Active coronary artery disease * Participation in structured exercise (\>2 times per week for 30 minutes or longer) * Smoking * Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids) * Renal insufficiency (serum creatinine \> 1.5mg/dl) * Chronic active liver disease (Bilirubin \> 17mmol/L, AST \> 144 IU/L, or ALT\>165IU/L) * Pregnancy or breastfeeding.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Jensen, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.