Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
ConditionObesity, Morbid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI 40 - 50 kg/m2.
Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gastric sleeve/bariatric surgery
Procedure/Surgeryweight loss
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Gastric sleeve surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
adipose macrophage content, adipose IL-6 and TNF gene expression
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
Time frame
Before bariatric surgery and approximately 1 year after surgery2
insulin regulation of lipolysis (IC50)
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
Time frame
Before bariatric surgery and approximately 1 year after surgerySecondary outcomes
1
adipocyte perilipin 1 and HSL and ATGL
These proteins will be measured using capillary Western methods.
Time frame
Before bariatric surgery and approximately 1 year after surgeryOther outcomes
1
Long-term, substantial weight loss and insulin regulation of lipolysis
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.
Time frame
1 year2
Long-term, substantial weight loss and insulin regulation of lipolysis
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov