A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of body mass index
研究概览
简要总结
Background and study aims:
Surgical and non-surgical normalization of body weight with obesity leads to a significant improvement in health and regression of metabolic syndrome. But as the reduction in body weight with obesity changes the life expectancy remains not clear enough.
The use of endoscopic staplers does not exclude the emergence of serious complications of surgery, for example, including bleeding and leakage in the stapler suture line. Therefore, the advantages of using a band in the bariatrics are justified from a security standpoint.
Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). The proposal to use for the staple-free (stepleless or steplerless) creation of a pouch (band-separated gastric bypass) with use for band a vascular prosthesis is justified, but it requires comparison of this method with a stapler variant.
An important issue is comparing surgical and non-surgical weight loss with obesity and metabolic syndrome and comparing life expectancy with confirmation of changes in telomere length.
This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), telomere length, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB). Additionally, surgical treatment will be compared with non-surgical treatment (hypocaloric diet therapy).
Who can participate? Obese adult patients with a BMI of between 30 kg/m2 and 50 kg/m2. What does the study involve? Participants are randomly allocated to one of three groups. Those in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second (B) group undergo the linear cutter stapler-separated mini-gastric bypass procedure. In three (C) group including standard lifestyle intervention on weight and hypocaloric diet therapy.
All patients are then followed up one month after surgery and again after 6 and, finally, 12 months after surgery where the changing body mass index, changes in co-morbidities, change telomere length and quality of life are assessed.
详细描述
Study hypothesis:
The increase in life expectancy depends on the degree of weight loss and the degree of regression of metabolic syndrome manifestations.
Ethics approval May 24, 2018, Ethics Committee of the Corporate Fund "University medical center".
Study design:
The interventional prospective randomized controlled clinical trial single-center study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
sealed non-transparent envelopes
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI from 30 to 50 kg / m2;
- •Metabolic syndrome (MetS) with abdominal adiposity if there are at least two components of MetS from the following: Increase in fasting plasma glucose: detected before diabetes (HbA1 = 5.7-6.4 or 3-fold increase in fasting plasma glucose:> 5.6 mmol / l); or previously diagnosed type 2 diabetes (HbA1> 6.5, or glucose> 6.1); Arterial hypertension AD 130 / 85 mmHg or receiving antihypertensive therapy; Increased triglyceride levels> 1.7 mmol / L or a specific treatment for this disorder; Reduction of high-density lipoproteins (HDL-C) <1.03 mmol / L in men and less than 1.29 mmol / L in women or receiving treatment for this disorder;
- •The possibility of treatment for 12 months and the possibility of follow up;
- •Informed written consent of the patient for randomization and treatment.
排除标准
- •Age is less than 18 or more than 65 years;
- •BMI less than 30 kg / m2 and more than 50 kg / m2;
- •Drug addiction and alcohol consumption;
- •Complete immobilization of the patient (paresis / paralysis);
- •Presence in the anamnesis bariatric procedures;
- •Insulin-dependent diabetes;
- •Mental disorders or taking antidepressants;
- •Socially vulnerable categories (according to ethical principles);
- •Patients who do not understand the purpose of the study;
- •Lack of informed written consent.
研究组 & 干预措施
Stapleless one anastomosis gastric bypass
Laparoscopic stapleless-separated one anastomosis (mini-) gastric bypass procedures
干预措施: Laparoscopic one anastomosis gastric bypass (Procedure)
Staple use mini-gastric bypass
Laparoscopic stapler-separated one anastomosis (mini-) gastric bypass procedures
干预措施: Laparoscopic one anastomosis gastric bypass (Procedure)
Hypocaloric diet therapy
Hypocaloric diet therapy with energy restriction (-500 kcal/d)
干预措施: Hypocaloric diet therapy (Dietary Supplement)
结局指标
主要结局
Change of body mass index
时间窗: Baseline, at 12 months after surgery
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
次要结局
- Changes of comorbidities(Baseline, at 12 months after surgery)
- Changes in the length of leukocyte telomere(Baseline, at 12 months after surgery)
- Change of Quality of life(at 12 months after surgery)
研究者
Oral Ospanov
Professor
University Medical Center, Kazakhstan