Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Официальное название

Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery

Обзор

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

Подробное описание

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 for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most effective treatment for morbid obesity with established long-term results of weight loss, remission of comorbid conditions and the improvement of Quality of Life (QoL). However, variability in these results after bariatric surgery is well known. Identifying preoperative predictors of postoperative weight loss and metabolic health is of clinical priority. Predictors could help further improve the efficacy of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery.

Первичные конечные точки

• Predictors of improvement in metabolic health - insulin sensitivity [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health - level of glucose control [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health - glucose [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health - insulin [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health - lipid profile [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health - biomarker inflammation [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of improvement in metabolic health [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss [Срок оценки: Baseline up to 5 years after surgery]

Вторичные конечные точки (12)

• Psychological factors - depression [Срок оценки: Baseline up to 5 years after surgery]
• Psychological factors - anxiety [Срок оценки: Baseline up to 5 years after surgery]
• Psychological factors - impulsivity [Срок оценки: Baseline up to 5 years after surgery]
• Psychological factors - impulsivity [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - food addiction [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - eating behaviour [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Quality of Life [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Quality of Life [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Quality of Life [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Impulsivity [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Impulsivity [Срок оценки: Baseline up to 5 years after surgery]
• Predictors of weight loss - Physical activity [Срок оценки: Baseline up to 5 years after surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 3 центра

• Nederlandse Obesitas Kliniek Gouda — Gouda
• Nederlandse Obesitas Kliniek Den Haag — The Hague
• Nederlandse Obesitas Kliniek Nieuwegein — Nieuwegein

Идентификаторы

NCT: NCT05987631 · 2021_136 · NL77692.018.21 · NTR9447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗