NCT05987631Recruiting
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 14 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 21 Apr 2023
- Start date
- 19 Jan 2023
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Obesity
- NCT number
- NCT05987631
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 19 Jan 2023 to the primary completion date, 31 Aug 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Use of any medication except for statins, antihypertensives (except for Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone
Other illness
- Any actual medical condition except for obesity related health issues or well treated hypothyroidism
- Coagulation disorders and/or use anticoagulants
- Diabetes mellitus type 2
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nederlandse Obesitas Kliniek Gouda Coordinator of this site? Confirm its status | Gouda | Netherlands | Not yet recruiting |
| Nederlandse Obesitas Kliniek Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Not yet recruiting |
| Nederlandse Obesitas Kliniek Den Haag Coordinator of this site? Confirm its status | The Hague | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.