Obesity overweight
Conditions
Interventions
None listed
Sponsors
Endocrinologie&metabolisme
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Ability to provide informed consent * Patient is >= 18 and = 40 kg/m2 or >= 35 kg/m2 with obesity related comorbidity * Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or Sleeve Gastrectomy (SG) * Stable weight 3 months prior to inclusion weight ( 5.6 mmol/L) or fasting insulin > 74 pmol/L) * Postmenopausal women (to prevent bias due to the effect of sex homones on insulin sensitivity)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients who do not understand the patient information letter * Any actual medical condition except for obesity related health issues or well treated hypothyroidism * Pregnancy anticipated in the first two years following surgery A potential subject who meet the following criteria will be excluded from participation in the subgroup of this study: * Coagulation disorders and/or use anticoagulants * Use of any medication except for statins, antihypertensives (except for ACE- or angiotensin receptor blockers) and thyroid hormone * Diabetes mellitus type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the preoperative blood samples and urine used for GWAS analysis, urine samples will be collected to evaluate predictors of response to surgery , based on results of GWAS analysis and omics analyses performed in previous SOPHIA studies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To study the predictive value of the measured preoperative biomarkers metabolic response and weight loss 3, 18 and 60 months after bariatric surgery. Specifically, we will assess: * pro- and anti-inflammatory circulating cytokines and chemokines * fasting insulin and glucose to calculate insulin sensitivity index and HbA1C * cardiorespiratory fitness and handgrip strength * questionnaires to assess eating behavior and psychological traits Metabolic response is defined as an improvement in insulin sensitivty assessed by HOMA-IR. - To get more mechanistic insight, the following metabolic assessment will be performed after an overnight fast: * Resting energy expenditure and substrate oxidation using indirect calorimetry after an overnight fast and during the hyperinsulinemic euglycemic clamp * Assessment of hepatic and muscle tissue insulin sensitivity using a stable isotope tracer (6,6 2H2 glucose) during a 2-step hyperinsulinemic euglycemic clamp * Assessment of adipose tissue insulin sensitivity by calculating the adipose tissue insulin resistance index and by measuring the percentage suppression of fatty acids during low dose insulin infusion (this method was previously validated by our group) * Assessment of the insulin signaling pathway in biopsies of skeletal muscle and subcutaneous fat by measuring mRNA expression and phosphorylation of key insulin signalling proteins * Assessment of liver fat and NAFLD criteria, mRNA expression and phosphorylation of the insulin signaling pathway as well as mRNA expression of key components (transcription factors and enzymes) in the de novo lipogenesis pathway in liver biopsies harvested during bariatric surgery | — |
Countries
Netherlands
Outcome results
None listed