Recruiting

Bariatric Surgery

Sponsor:

Mayo Clinic

Code:

NCT03868592

Conditions

Obesity, Morbid

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Gastric sleeve/bariatric surgery

Study Details

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

Study ID

NCT03868592

Start date

Aug 1, 2019

Status verified date

Feb, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Gastric sleeve surgery

before and after weight loss from bariatric surgery

Interventions

Gastric sleeve/bariatric surgery

weight loss

Primary outcome measure

  • adipose macrophage content, adipose IL-6 and TNF gene expression [ Time Frame: Before bariatric surgery and approximately 1 year after surgery ]
  • insulin regulation of lipolysis (IC50) [ Time Frame: Before bariatric surgery and approximately 1 year after surgery ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 559055

Contacts

Reich Pamela

5072556062reich.pamela@mayo.edu

Principal Investigator:

Michael D Jensen, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-03.