Long-term Impact of Surgically Induced Rapid Weight Loss on Telomere Length and Its Potential Implications in the Genesis and Prevention of Neoplastic Disease Processes in Subjects With Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Telomere length
研究概览
简要总结
The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.
详细描述
This study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening.
The investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction.
It is a prospective, single-center study including patients with obesity class II or more (Body Mass Index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 35 kg/m2 without previous bariatric surgery (control group) OR
- •Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight (treatment group)
排除标准
- •under 18 years of age
- •no informed consent
结局指标
主要结局
Telomere length
时间窗: 1 day
Difference in terms of telomere length between patients with obesity class II or more (Body Mass Index \[BMI\] ≥ 35kg/m2) and patients after metabolic and bariatric surgery.
次要结局
- Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission)(1 day)
- Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss)(1 day)
- Oxidative stress (Interleukin-1β, Interleukin-6, TNF-α)(1 day)
- Lifestyle (Simple Lifestyle Indicator Questionnaire)(1 day)
研究者
Emanuele LoMenzo
Prof.
The Cleveland Clinic