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临床试验/NCT01572090
NCT01572090Unknown不适用

Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment on Body Composition, Adipokines, Gastro-intestinal Hormones and Cardiometabolic Risk Factors

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
Change in body fat

研究概览

简要总结

Patients with overweight or obesity are in need to loose weight and represent a particularly challenging medical condition. Undoubtedly, any intervention achieving a negative energy balance over an extended time period will result in weight loss. Although several treatment modalities are available, currently the most extended approaches are lifestyle changes, pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the main therapeutic strategies involve either conventional treatment or bariatric surgery. Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per week. The main modifiable factors affecting energy balance are dietary energy intake and energy expended through physical activity. In spite of the difficulty in achieving relevant and sustained weight loss via the conventional approach, some patients are successful in reducing weight and obesity-associated complications. Bariatric surgery has proved to be the most effective long-term treatment for weight loss and comorbidity improvement. While some of the surgery-induced benefits are directly dependent on adipose tissue reduction, others are due to specific gastrointestinal changes that take place early on and before any significant effects on body weight are observed. The present study contemplates the determination and comparison of the anthropometric and metabolic changes produced by the conventional and surgery-induced treatment modalities. Particular emphasis will be placed on the potential differential effects between conventional and surgical weight loss on body composition changes, circulating adipokines and gastrointestinal hormones together with their subsequent impact on cardiometabolic risk factors.

详细描述

In spite of the recognition of obesity as a serious public health problem due to its well-known increased risk for the development of type 2 diabetes hypertension, coronary heart disease, sleep-breathing disorders, and certain forms of cancer, among others, it is proving extraordinarily difficult to halt this pandemia. Strictly speaking obesity does not refer to an excess weight or weight to height ratio. In fact, the World Health Organization defines obesity as a state of increased adipose tissue of sufficient magnitude to produce adverse health consequences. Thus, in order to better define the effects and benefits of weight loss it is important to address the impact on body fat changes. Given the limited approved anti-obesity drugs, the main therapeutic strategies involve either conventional treatment or bariatric surgery. The main modifiable factors affecting energy balance are dietary energy intake and energy expended through physical activity. In spite of the difficulty in achieving relevant and sustained weight loss via the conventional approach, some patients are successful in reducing weight and obesity-associated complications. Bariatric surgery has proved to be the most effective long-term treatment for weight loss and comorbidity improvement. While some of the surgery-induced benefits are directly dependent on adipose tissue reduction, others are due to specific gastrointestinal changes that take place early on and before any significant effects on body weight are observed. Noteworthy, currently available bariatric procedures differ on their impact on these aspects. The present study contemplates the determination and comparison of the anthropometric and metabolic changes produced by the conventional and surgery-induced treatment modalities. Particular emphasis will be placed on the potential differential effects between conventional and surgical weight loss on energy intake, energy expenditure, body composition changes, circulating adipokines and gastrointestinal hormones together with their subsequent impact on cardiometabolic risk factors. The conventional weight-reduction program (CONV) will pursue a safe weight loss rate of 0,5-1,0 kg per week. The surgery-induced weight loss will be achieved by two of the most frequently used bariatric operations, the sleeve gastrectomy [SG (which implies a restrictive component)] and the Roux-en-Y gastric bypass [RYGB (which combines a restrictive and a malabsorptive component)].

The purpose of the study is to determine the effect of three weight loss procedures that differ on their manipulation of the anatomical and functional characteristics of the gastrointestinal tract. While in the conventional treatment the gastrointestinal system remains intact, in the SG only the stomach is manipulated as opposed to the RYGB, where both the stomach and the small intestine are operated on. Since bariatric surgery is well known to induce partial or total remission of type 2 diabetes mellitus, the effects of the three different weight loss procedures will be assessed separately in obese normoglycemic and obese type 2 diabetic individuals.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 21 and 65 years.
  • Obesity as defined by World Health Organization criteria.
  • For bariatric surgery patients: qualified for obesity surgery by the -Multidisciplinary Obesity Team of the Clinica Universidad de Navarra
  • For type 2 diabetic patients: T2D diagnosis confirmed by either fasting plasma glucose ≥126 mg/dL on two separate occasions, or fasting plasma glucose ≥126 mg/dL and plasma glucose ≥140 mg/dL 2 h after OGTT, or treatment with anti-diabetic medication in accordance with good clinical practice with and well-documented information on diagnosis, history, treatment(s) and HbA1c data.
  • No major organ disease unrelated to excess body weight.
  • Mentally able to understand the study and willingness to participate in the study.

排除标准

  • Pregnancy/lactation
  • Poor overall general health
  • Drug and/or alcohol addiction
  • Prior bariatric or gastrointestinal surgery
  • Active gastric or intestinal tract disease
  • Thyroid disease
  • Type 1 diabetes mellitus
  • Portal hypertension and/or cirrhosis
  • Malignancies
  • History of eating disorders or major psychiatric illness
  • Unable to communicate with study staff

结局指标

主要结局

Change in body fat

时间窗: Baseline, 1, 6, 12, and 24 months

Body fat will be assessed by air-displacement plethysmography (Bod-Pod) over the duration of the intervention.

次要结局

  • Change in glycemic control(Baseline, 1, 6, 12 and 24 months)
  • Change in gastrointestinal hormones(Baseline, 1, 6, 12 and 24 months)
  • Change in BMI(Baseline, 1, 6, 12 and 24 months)
  • Change in gustatory threshold(Baseline, 1, 6, 12 and 24 months)
  • Change in energy balance(Baseline, 1, 6, 12 and 24 months)
  • Change in cardiovascular risk factors(Baseline, 1, 6, 12 and 24 months)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gema Frühbeck Martínez

MD, PhD

Clinica Universidad de Navarra, Universidad de Navarra

研究点 (1)

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