NCT05987631 Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
| NCT ID | NCT05987631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Obesity, Morbid |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2024-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2023-01-19 with a primary completion date of 2024-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Mireille JM Serlie, Prof. Dr.
PRINCIPAL INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frequently Asked Questions
Who can join the NCT05987631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05987631 currently recruiting?
Yes, NCT05987631 is actively recruiting participants. Contact the research team at r.vandermeer1@amsterdamumc.nl for enrollment information.
Where is the NCT05987631 trial being conducted?
This trial is being conducted at Gouda, Netherlands, The Hague, Netherlands, Nieuwegein, Netherlands.
Who is sponsoring the NCT05987631 clinical trial?
NCT05987631 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Mireille JM Serlie, Prof. Dr. at Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 1,200 participants.
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