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NCT Number: NCT03868592

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 559055, United States

Location status: Recruiting

Location contact

Michael D Jensen, MD

PRINCIPAL_INVESTIGATOR

Reich Pamela

CONTACT

[email protected]

5072556062

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastric sleeve/bariatric surgery

Procedure

weight loss

Primary outcomes

  1. adipose macrophage content, adipose IL-6 and TNF gene expression

    Time frame: 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

  2. insulin regulation of lipolysis (IC50)

    Time frame: 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 outcomes

  1. adipocyte perilipin 1 and HSL and ATGL

    Time frame: Before bariatric surgery and approximately 1 year after surgery

    These proteins will be measured using capillary Western methods.

Other outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2019
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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