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
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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Nederlandse Obesitas Kliniek Gouda
Gouda, South Holland, Netherlands
NOT_YET_RECRUITINGNederlandse Obesitas Kliniek Den Haag
The Hague, South Holland, Netherlands
RECRUITINGNederlandse Obesitas Kliniek Nieuwegein
Nieuwegein, Utrecht, Netherlands
NOT_YET_RECRUITINGPredictors of improvement in metabolic health - insulin sensitivity
HOMA-IR
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - level of glucose control
HbA1C (mmol/mol)
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - glucose
Fasting glucose (mmol/L)
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - insulin
Insulin (pmol/L)
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - lipid profile
Lipids (mmol/L)
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - biomarker inflammation
CRP (mg/L)
Time frame: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health
Genetic variants using GWAS analysis
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss
Genetic variants using GWAS analysis
Time frame: Baseline up to 5 years after surgery
Psychological factors - depression
Patient-Reported Outcomes Measurement Information System Depression (PROMIS-D: validated questionnaire for bariatric surgery. PROMIS-D: range in score from 8 to 40, higher scores indicating greater severity of depression
Time frame: Baseline up to 5 years after surgery
Psychological factors - anxiety
Patient-Reported Outcomes Measurement Information System Anxiety (PROMIS-A): validated questionnaire for bariatric surgery. PROMIS-A: range in score from 7 to 35, higher scores indicating greater severity of anxiety.
Time frame: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
Time frame: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - food addiction
Food addiction scale (YFAS 2.0): validated questionnaire to assess food addiction. YFAS 2.0 includes two scoring methods, a continuous symptom count and a diagnosis of food addiction. Continious symptom count ranges from zero to eleven, Diagnosis of food addiction: no food addiction (0-1 symptoms), a mild food addicition (2-3 symptoms), a moderate food addiction (4-5 symptoms), or a severe food addiction (\>6 symptoms).
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - eating behaviour
Dutch Eating Behaviour Questionnaire (DEBQ): validated questionnaire to assess eating behaviour. DEBQ consists of 33 items.Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
Selfesteem scale of Impact of Weight on Quality of Life - lite (IWQOL-lite): validated questionnaire after weight loss interventions. The self-esteem scale consists of 7 items. Each item is rated on a 5-point scale. Higher scores represent better quality of life.
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
OBESI-Q (Obesity): validated questionnaire for reporting Health Related Quality of Life. Outcome is expressed on a 100 point scale, a higher score is higher quality of life, with the exception of item "Excess skin".
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
EuroQuality of Life (EQ-5D): validated questionnaire for reporting Quality of Life after bariatric surgery. Each item is rated on a 5-point scale. Higher scores represent lower reported quality of life.
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Physical activity
Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH): validated questionnaire to assess physical activity. The SQUASH measures the frequency, duration and intensity of 5 different physical activities: commuting (traveling to and from work/study), housekeeping , activities at work, leisure time, and sports. A higher score = more time spend on physical activities.
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in weight loss
Males versus females regarding weight loss (kg) and percentage of total weight loss
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - insulin sensitivity
Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - improvement of diabetes
Males versus females regarding HbA1c values and diabetic drug use
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - lipid
Males versus females regarding lipids (mmol/L) and lipid-lowering agents use
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - hypertension
Males versus females regarding blood pressure (mmHg) and anithypertensive medication use
Time frame: Baseline up to 5 years after surgery
Peripheral insulin sensitivity
In a subset of 40 patients insulin sensitivity will be assessed using hyperinsulinemic euglycemic clamps, and adipose tissue and skeletal muscle biopsies will be taken to assess insulin signalling (expression of mRNA and phosphorylated proteins)
Time frame: Before and 3 and 18 months after bariatric surgery
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