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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03868592

Enrollment

Registered

2019-03-11

Start date

2019-08-01

Completion date

2027-05-01

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

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

Interventions

PROCEDUREGastric sleeve/bariatric surgery

weight loss

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael D Jensen, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026