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Search / Trial NCT05987631

Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Obesity Bariatric Surgery Metabolic Health Weight Loss Predictors

ClinConnect Summary

This clinical trial is studying how different factors before surgery can predict weight loss and improvements in health after bariatric surgery, which is a procedure to help individuals with severe obesity lose weight. The researchers are particularly interested in aspects like inflammation, insulin sensitivity (how well your body uses insulin), psychological traits, eating habits, and fitness levels. The goal is to understand what might help people do better after surgery.

To participate, you need to be between 18 and 75 years old, have a body mass index (BMI) of 40 or higher, or 35 or higher with related health issues. You should also be scheduled for either a Roux-en-Y gastric bypass or a sleeve gastrectomy and have maintained a stable weight for three months prior to the study. If you join, you can expect to undergo assessments and tests to gather information about your health and habits. It's important to know that certain medical conditions, pregnancy, and specific medications may prevent you from participating.

Gender

ALL

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

About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)

The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.

Locations

Nieuwegein, Utrecht, Netherlands

Den Haag, Zuid Holland, Netherlands

Gouda, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Mireille JM Serlie, Prof. Dr.

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Valerie M Monpellier, Dr.

Principal Investigator

Obesitas Nederland B.V.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported