Clinical trial
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Recruiting now · Not applicable · 1 countries · Registry ID NCT05987631
Recruiting nowNot applicableObservational
What this study is about
In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Morbid, Insulin Sensitivity, Bariatric Surgery Candidate, Feeding Behavior
Full registry criteria
Inclusion Criteria: * Ability to provide informed consent * Patient is ≥ 18 and ≤ 75 years old * BMI ≥ 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 (\<10% change in body weight for 3 months prior to assessments) In order to be eligible to participate in the subgroup of this study, we will use the following inclusion criteria: * Ability to provide informed consent * Patient is ≥ 18 and ≤ 75 years old * BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity * Patients scheduled for RYGB * Patients who are insulin resistant (impaired fasting glucose (\> 5.6 mmol/L) or fasting insulin \> 74 pmol/L) * Postmenopausal women (to prevent bias due to the effect of sex hormones on insulin sensitivity) Exclusion Criteria: * 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 Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone * Diabetes mellitus type 2
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
Predictors of improvement in metabolic health - insulin sensitivityBaseline up to 5 years after surgery
HOMA-IR
Predictors of improvement in metabolic health - level of glucose controlBaseline up to 5 years after surgery
HbA1C (mmol/mol)
Predictors of improvement in metabolic health - glucoseBaseline up to 5 years after surgery
Fasting glucose (mmol/L)
Predictors of improvement in metabolic health - insulinBaseline up to 5 years after surgery
Insulin (pmol/L)
Predictors of improvement in metabolic health - lipid profileBaseline up to 5 years after surgery
Lipids (mmol/L)
Predictors of improvement in metabolic health - biomarker inflammationBaseline up to 5 years after surgery
CRP (mg/L)
Predictors of improvement in metabolic healthBaseline up to 5 years after surgery
Genetic variants using GWAS analysis
Predictors of weight lossBaseline up to 5 years after surgery
Genetic variants using GWAS analysis
Study locations
3 locations were listed when this page was built. The first 40 are shown.
Nederlandse Obesitas Kliniek Gouda🇳🇱 Gouda, South Holland, Netherlands
Rieneke van der Meer, Drs.Contact
Nederlandse Obesitas Kliniek Nieuwegein🇳🇱 Nieuwegein, Utrecht, Netherlands
Lianda Luijpers, Drs.Contact
Nederlandse Obesitas Kliniek Den Haag🇳🇱 The Hague, South Holland, Netherlands
Rieneke van der Meer, Drs.Contact