Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid, Insulin Sensitivity, Bariatric Surgery Candidate, Feeding Behavior. Basic parameters: 18 years — 75 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
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
Overview
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
Detailed description
Obesity is the result of a complex interplay between genetic and epigenetic predisposition, environment, physical activity, nutrition and psychology. It is a debilitating disorder and a risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most effective treatment for morbid obesity with established long-term results of weight loss, remission of comorbid conditions and the improvement of Quality of Life (QoL). However, variability in these results after bariatric surgery is well known. Identifying preoperative predictors of postoperative weight loss and metabolic health is of clinical priority. Predictors could help further improve the efficacy of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery.
Primary outcome measures
- Predictors of improvement in metabolic health - insulin sensitivity [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health - level of glucose control [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health - glucose [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health - insulin [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health - lipid profile [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health - biomarker inflammation [Time frame: Baseline up to 5 years after surgery]
- Predictors of improvement in metabolic health [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss [Time frame: Baseline up to 5 years after surgery]
Secondary outcome measures (12)
- Psychological factors - depression [Time frame: Baseline up to 5 years after surgery]
- Psychological factors - anxiety [Time frame: Baseline up to 5 years after surgery]
- Psychological factors - impulsivity [Time frame: Baseline up to 5 years after surgery]
- Psychological factors - impulsivity [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - food addiction [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - eating behaviour [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Quality of Life [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Quality of Life [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Quality of Life [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Impulsivity [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Impulsivity [Time frame: Baseline up to 5 years after surgery]
- Predictors of weight loss - Physical activity [Time frame: Baseline up to 5 years after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 3 centers
- Nederlandse Obesitas Kliniek Gouda — Gouda
- Nederlandse Obesitas Kliniek Den Haag — The Hague
- Nederlandse Obesitas Kliniek Nieuwegein — Nieuwegein
Identifiers
NCT: NCT05987631 · 2021_136 · NL77692.018.21 · NTR9447