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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: Gastric sleeve/bariatric surgery

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 559055
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Michael D Jensen, MD
      • Contact: Reich Pamela; Phone Number: 5072556062; Email: reich.pamela@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric sleeve surgery; before and after weight loss from bariatric surgery	Procedure: Gastric sleeve/bariatric surgery; weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adipose macrophage content, adipose IL-6 and TNF gene expression	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	Before bariatric surgery and approximately 1 year after surgery
insulin regulation of lipolysis (IC50)	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	Before bariatric surgery and approximately 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adipocyte perilipin 1 and HSL and ATGL	These proteins will be measured using capillary Western methods.	Before bariatric surgery and approximately 1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term, substantial weight loss and insulin regulation of lipolysis	Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by changes in adipocyte perilipin 1 dephosphorylation in response to insulin.	1 year
Long-term, substantial weight loss and insulin regulation of lipolysis	Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by changes in adipocyte HSL dephosphorylation in response to insulin.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael D Jensen, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid; Therapeutics; Surgical Procedures, Operative; Bariatrics; Obesity Management; Bariatric Surgery
• Other Study ID Numbers: 17-005349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No