This study is part of the international, multicentre European research project: SOPHIA (Stratification of Obese Phenotypes to Optimize Future Obesity Therapy). The overall objective of SOPHIA is to optimize treatment outcomes of obesity. We will…
ID
Bron
Verkorte titel
Aandoening
Obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To validate biomarkers of response to bariatric surgery and to develop algorithms, which combine these variables, to predict individual responses.
Achtergrond van het onderzoek
Obesity is the result of a complex interplay between genetics and epigenetics predisposition, environment, nutrition and psychology. It is a debilitating disease and a risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia. Surgery has proven to be the most effective treatment for morbid obesity with established positive 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 weight loss and metabolic health is of clinical priority. Predictors could help further improve the quality of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery. This study is part of the international, multicentre European research project: SOPHIA.
Doel van het onderzoek
This study is part of the international, multicentre European research project: SOPHIA (Stratification of Obese Phenotypes to Optimize Future Obesity Therapy). The overall objective of SOPHIA is to optimize treatment outcomes of obesity. We will validate the treatment response and clinical utility of identified biomarkers of response to bariatric surgery, discovered in obesity intervention studies (NL75166.018.20, NTR NL8865), in a population who undergoes surgical treatment. Furthermore, we will evaluate eligibility of biological and hormonal markers as predictors of weight loss and improvement of metabolic health and QOL after bariatric surgery.
Onderzoeksopzet
presurgery and postsurgery timepoints: 3 -12- 18- 60 months
Publiek
Rieneke van der Meer
+31 653148089
r.vandermeer1@amsterdamumc.nl
Wetenschappelijk
Rieneke van der Meer
+31 653148089
r.vandermeer1@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
● 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 or Sleeve Gastrectomy
● Stable weight 3 months prior to inclusion weight (<10% change in body weight for 3 months prior to assessments)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
● Patients who do not understand the patient information letter
● Coagulation disorders
● Type 1 diabetes
● Severe liver disease
● Renal dysfunction
● Pregnancy anticipated in the first two years following surgery
● Use of antibiotics in last 6 months prior to inclusion
● Use of probiotics in last 6 months prior to inclusion
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9447 |
| Ander register | METC AMC : 77692 |