Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
NCT ID: NCT05987631
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2023-01-19
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Obesitas Kliniek B.V.
UNKNOWN
Radboud University Medical Center
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Mireille JM Serlie
Prof. Dr. Mireille JM Serlie
Principal Investigators
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Mireille JM Serlie, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Valerie M Monpellier, Dr.
Role: PRINCIPAL_INVESTIGATOR
Obesitas Nederland B.V.
Locations
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Nederlandse Obesitas Kliniek Gouda
Gouda, South Holland, Netherlands
Nederlandse Obesitas Kliniek Den Haag
The Hague, South Holland, Netherlands
Nederlandse Obesitas Kliniek Nieuwegein
Nieuwegein, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL77692.018.21
Identifier Type: OTHER
Identifier Source: secondary_id
NTR9447
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021_136
Identifier Type: -
Identifier Source: org_study_id
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