Status:
RECRUITING
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Obesitas Kliniek B.V.
Radboud University Medical Center
Conditions:
Obesity, Morbid
Insulin Sensitivity
Eligibility:
All Genders
18-75 years
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 sensiti...
Detailed Description
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05987631
Start Date
January 19 2023
End Date
August 31 2027
Last Update
August 14 2023
Active Locations (3)
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1
Nederlandse Obesitas Kliniek Gouda
Gouda, South Holland, Netherlands, 2803PW
2
Nederlandse Obesitas Kliniek Den Haag
The Hague, South Holland, Netherlands, 2591XR
3
Nederlandse Obesitas Kliniek Nieuwegein
Nieuwegein, Utrecht, Netherlands, 3431HK