Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- insulin regulation of lipolysis (IC50)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI 40 - 50 kg/m
- •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)
- •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.
Arms & Interventions
Gastric sleeve surgery
before and after weight loss from bariatric surgery
Intervention: Gastric sleeve/bariatric surgery (Procedure)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- adipocyte perilipin 1 and HSL and ATGL(Before bariatric surgery and approximately 1 year after surgery)
Investigators
Michael D. Jensen
Principal Investigator
Mayo Clinic