Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Recruiting now

Conditions studied: Obesity, Morbid, Insulin Sensitivity, Bariatric Surgery Candidate, Feeding Behavior

In brief

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

Key facts

Study ID

NCT05987631

Run by

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

People needed

1200

Starts

2023-01-19

Expected to finish

2027-08-31

Last updated by the study team

2023-08-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Nederlandse Obesitas Kliniek Den Haag — The Hague, South Holland, Netherlands (enrolling)
• Nederlandse Obesitas Kliniek Gouda — Gouda, South Holland, Netherlands
• Nederlandse Obesitas Kliniek Nieuwegein — Nieuwegein, Utrecht, Netherlands

Full record on ClinicalTrials.gov

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