Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Predictors of improvement in metabolic health - insulin sensitivity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Predictors of improvement in metabolic health - insulin sensitivity
时间窗: Baseline up to 5 years after surgery
HOMA-IR
Predictors of improvement in metabolic health - level of glucose control
时间窗: Baseline up to 5 years after surgery
HbA1C (mmol/mol)
Predictors of improvement in metabolic health - insulin
时间窗: Baseline up to 5 years after surgery
Insulin (pmol/L)
Predictors of weight loss
时间窗: Baseline up to 5 years after surgery
Genetic variants using GWAS analysis
Predictors of improvement in metabolic health - lipid profile
时间窗: Baseline up to 5 years after surgery
Lipids (mmol/L)
Predictors of improvement in metabolic health - biomarker inflammation
时间窗: Baseline up to 5 years after surgery
CRP (mg/L)
Predictors of improvement in metabolic health
时间窗: Baseline up to 5 years after surgery
Genetic variants using GWAS analysis
Predictors of improvement in metabolic health - glucose
时间窗: Baseline up to 5 years after surgery
Fasting glucose (mmol/L)
次要结局
- Psychological factors - depression(Baseline up to 5 years after surgery)
- Sexual dimorphism in restoration of metabolic health - insulin sensitivity(Baseline up to 5 years after surgery)
- Sexual dimorphism in restoration of metabolic health - hypertension(Baseline up to 5 years after surgery)
- Sexual dimorphism in restoration of metabolic health - improvement of diabetes(Baseline up to 5 years after surgery)
- Psychological factors - impulsivity(Baseline up to 5 years after surgery)
- Predictors of weight loss - Quality of Life(Baseline up to 5 years after surgery)
- Predictors of weight loss - food addiction(Baseline up to 5 years after surgery)
- Predictors of weight loss - eating behaviour(Baseline up to 5 years after surgery)
- Predictors of weight loss - Physical activity(Baseline up to 5 years after surgery)
- Sexual dimorphism in weight loss(Baseline up to 5 years after surgery)
- Peripheral insulin sensitivity(Before and 3 and 18 months after bariatric surgery)
- Psychological factors - anxiety(Baseline up to 5 years after surgery)
- Sexual dimorphism in restoration of metabolic health - lipid(Baseline up to 5 years after surgery)
- Predictors of weight loss - Impulsivity(Baseline up to 5 years after surgery)
研究者
Prof. Dr. Mireille JM Serlie
Prof. Dr. Mireille JM Serlie
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)