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

NCT03868592 | Recruiting

• 1 other identifier: 17-005349
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• adipocyte perilipin 1 and HSL and ATGL

  Before bariatric surgery and approximately 1 year after surgery

Other Outcomes (2)

• Long-term, substantial weight loss and insulin regulation of lipolysis

  1 year

• Long-term, substantial weight loss and insulin regulation of lipolysis

  1 year

Study Arms (1)

Gastric sleeve surgery

EXPERIMENTAL

before and after weight loss from bariatric surgery

Procedure: Gastric sleeve/bariatric surgery

Interventions

Gastric sleeve/bariatric surgery PROCEDURE

weight loss

Gastric sleeve surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 40 - 50 kg/m2.
• Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 559055, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Michael D Jensen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study insulin action and adipose function before and after weight loss from gastric sleeve surgery

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: August 1, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)