Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric sleeve/bariatric surgery.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Gastric sleeve/bariatric surgery
weight loss
Primary outcome measures
- 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]
Secondary outcome measures (1)
- adipocyte perilipin 1 and HSL and ATGL [Time frame: Before bariatric surgery and approximately 1 year after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT03868592 · 17-005349