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临床试验/NCT06820047
NCT06820047已完成不适用

Impact of Sleeve Gastrectomy Versus Intensive Lifestyle Modifications with Obesity Management Medications on BMI Trajectory and Target Attainment: a Prospective Matched Cohort Study

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
190
试验地点
2
主要终点
Weight modifications

研究概览

简要总结

Obesity is a widespread and preventable condition affecting over a billion people globally, with rates expected to rise significantly by 2030. It increases the risk of chronic illnesses such as diabetes, cardiovascular disease, certain cancers, mental health issues, and premature death. While bariatric surgery, such as sleeve gastrectomy (SG), is the most effective long-term weight-loss solution, many individuals are ineligible or unwilling to undergo surgery. Semaglutide, a medication that suppresses appetite and aids in weight loss when paired with diet and exercise, offers a promising alternative. This study compared the effectiveness of SG and an intensive weight-loss program combining diet, exercise, and semaglutide. Conducted over a year with 190 participants split into two groups matched by BMI, the SG group underwent surgery, while the other group followed a calorie-restricted diet, intensive exercise, and weekly semaglutide injections. Changes in BMI, weight, and comorbidities such as diabetes and high blood pressure were evaluated, aiming to determine which approach was more effective in managing obesity.

详细描述

Obesity is a complex and largely preventable disease affecting over a third of the global population. As of 2022, more than 1 billion individuals worldwide were living with obesity, and projections indicate that by 2030, 38% of the adult population will be overweight, with an additional 20% affected by obesity. This condition significantly increases the risk of chronic diseases, including type 2 diabetes (T2D), cardiovascular disease (CVD), certain cancers, and mental health disorders such as depression, as well as premature mortality.

Given the rising prevalence of obesity, effective intervention strategies are critical. Bariatric and metabolic surgery remains the most effective approach for sustained weight loss, with procedures recommended for individuals with a body mass index (BMI) ≥35 kg/m², regardless of comorbidities. Metabolic surgery has demonstrated superior outcomes in reducing blood glucose levels and achieving higher remission rates of T2D compared to lifestyle and pharmacological interventions. However, surgical interventions are typically reserved for individuals who have failed prior dietary and exercise-based interventions, have adequate motivation, and do not suffer from severe psychiatric conditions.

For individuals who are ineligible for or unwilling to undergo bariatric surgery, alternative treatment options are necessary. One such option is semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, which mimics endogenous GLP-1 to suppress appetite, reduce glucagon release, and promote satiety. Studies have shown that GLP-1 receptor agonists contribute to significant weight loss and metabolic improvements.

This study aims to compare the efficacy of intensive lifestyle modifications combined with obesity management medications (ILM/OMMs) versus sleeve gastrectomy (SG) in terms of BMI trajectory and metabolic outcomes over a 1-year period. The primary endpoint is the change in BMI at 1 year, while secondary endpoints include changes in weight, plasma glucose levels, lipid profiles, and obesity-related comorbidities such as hypertension, CVD, dyslipidemia, and T2D.

Methods Study Design This study is a 1-year, prospective, multicenter, matched cohort study comparing ILM/OMMs with SG. Patients were recruited from the weight-loss clinics of Sapienza University Hospital and Catholic University Hospital in Rome, Italy. Eligible patients were allocated to either ILM/OMMs or SG. Ninety-five patients per arm were matched in a 1:1 ratio, based on sex, age, BMI, and diabetes duration.

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
19 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 19 and 69 years with stable body weight in the past 6 months;
  • •BMI ≥35 kg/m2 and at least one or more obesity-related co-morbidities (T2D, hypertension, sleep apnea and other respiratory disorders, metabolic-associated fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease)
  • •BMI≥40 kg/m2 with or without related comorbidities

排除标准

  • •Previous bariatric surgery;
  • •History of pancreatitis;
  • •Severe psychiatric disorders;
  • •Personal or familiar history of endocrine cancers.

结局指标

主要结局

Weight modifications

时间窗: 12 months

Change in body mass index (expressed as weight in kilograms divided by height in meters squared, kg/m\^2) at 1 year and time to reach 25% total weight loss (%TWL) (weight will be reported in kilograms)

次要结局

  • Comorbidity resolution rate(12 months)
  • Glycemic control changes(12 months)
  • Lipid profile changes(12 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lidia Castagneto Gissey

Prof

University of Roma La Sapienza

研究点 (2)

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