Identifying predictors of weight loss and metabolic health after bariatric surgery
Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
This study is trying to find out what factors can help predict how well people with insulin resistance will lose weight and improve their health after having bariatric surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 3 sites (Gouda, South Holland and 2 other locations) |
| Trial ID | NCT05987631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify preoperative predictors that influence weight loss and metabolic health improvements following bariatric surgery. The research focuses on various factors including inflammation, insulin sensitivity, psychological traits, feeding behaviors, and cardiorespiratory fitness. By understanding these predictors, the study seeks to tailor treatment approaches for individuals undergoing bariatric surgery, thereby optimizing their outcomes. The study will involve patients scheduled for Roux-en-Y gastric bypass or Sleeve Gastrectomy, with a focus on those who are insulin resistant.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a BMI of 40 kg/m2 or higher, or 35 kg/m2 with obesity-related comorbidities, who are scheduled for primary bariatric procedures.
Not a fit: Patients with medical conditions unrelated to obesity or those with poorly managed hypothyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients undergoing bariatric surgery.
How similar studies have performed: Other studies have shown success in identifying predictors of outcomes after bariatric surgery, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gouda, South Holland and 2 other locations
- Nederlandse Obesitas Kliniek Gouda — Gouda, South Holland, Netherlands (Not_yet_recruiting)
- Nederlandse Obesitas Kliniek Den Haag — The Hague, South Holland, Netherlands (Recruiting)
- Nederlandse Obesitas Kliniek Nieuwegein — Nieuwegein, Utrecht, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Mireille JM Serlie, Prof. Dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Rieneke van der Meer, Drs.
- Email: r.vandermeer1@amsterdamumc.nl
- Phone: +31703204703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.