Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Not Applicable

Recruiting

• Conditions: Obesity, Morbid
• Interventions: Procedure: Gastric sleeve/bariatric surgery

• Registration Number: NCT03868592
• Lead Sponsor: Mayo Clinic

Brief Summary

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

Detailed Description

The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric sleeve surgery	Gastric sleeve/bariatric surgery	before and after weight loss from bariatric surgery

Primary Outcome Measures

Name	Time	Method
insulin regulation of lipolysis (IC50)	Before bariatric surgery and approximately 1 year after surgery	The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics
adipose macrophage content, adipose IL-6 and TNF gene expression	Before bariatric surgery and approximately 1 year after surgery	Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured

Secondary Outcome Measures

Name	Time	Method
adipocyte perilipin 1 and HSL and ATGL	Before bariatric surgery and approximately 1 year after surgery	These proteins will be measured using capillary Western methods.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States