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临床试验/NCT05896358
NCT05896358进行中(未招募)不适用

Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
weight change

研究概览

简要总结

Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

详细描述

Metabolic surgery is, to date, the strategy for the treatment of obesity with the greatest long-term efficacy. However, especially in those lost to surgical and nutritional follow-up, weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. In particular, depending on the type of surgery considered, it has been observed that up to 40% of subjects undergoing surgery report a WR long term, where data on IWL are still insufficient to draw well-defined estimates. WR and IWL are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed, with increased risk of complications and little effect.

The ketogenic diet is one of the pivotal dietary therapies for the treatment of obesity, with excellent evidence in terms of weight loss and improvement in complications of excess weight. Very little data is available regarding its application on post bariatric patients: Correa and colleagues reported in a retrospective case series the efficacy and safety of a very low calorie ketogenic diet (VLCKD) in 11 patients with IWL or WR after gastric bypass, reporting a good safety profile, good tolerability, and an average weight loss of 9 kg in 2 months of therapy. Although promising, the data in the literature are extremely scarce, and therefore ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL.

The objective of this study is to test whether the application of a ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

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

入选标准

  • obesity (BMI ≥ 30 Kg/m2)

排除标准

  • Type 1 diabetes mellitus
  • Renal failure (GFR<60)
  • Liver failure (decompensated cirrhosis)
  • Congenital metabolic diseases
  • Pregnancy
  • lactation
  • Major psychiatric disorder
  • Alcoholism
  • drug addiction
  • patients who are not self-sufficient and without adequate family and social support

结局指标

主要结局

weight change

时间窗: at baseline and right after the dietary intervention (8 weeks)

body mass change (kg) within and between groups

次要结局

  • waist circumference change(at baseline and right after the dietary intervention (8 weeks))
  • glucose concentration change(at baseline and right after the dietary intervention (8 weeks))
  • insulin concentration change(at baseline and right after the dietary intervention (8 weeks))
  • uric acid concentration change(at baseline and right after the dietary intervention (8 weeks))
  • triglycerides concentration change(at baseline and right after the dietary intervention (8 weeks))
  • muscle mass change(at baseline and right after the dietary intervention (8 weeks))
  • body fat change(at baseline and right after the dietary intervention (8 weeks))
  • cholesterol concentration change(at baseline and right after the dietary intervention (8 weeks))
  • mean blood pressure change(at baseline and right after the dietary intervention (8 weeks))
  • creatinine concentration change(at baseline and right after the dietary intervention (8 weeks))

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

Lucio Gnessi

Full professor

University of Roma La Sapienza

研究点 (1)

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