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临床试验/NCT04587076
NCT04587076已完成不适用

Evaluation of Protein Intake, Vitamin, Mineral, and Trace Element Supplementation After Bariatric Surgery According to the German S3 Guidelines - What Effects do Age, Sex, and Socio-economic Status Have on Adherence?

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年7月3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
38
试验地点
1
主要终点
Therapy Adherence Across Groups of Socio-Economic Status

研究概览

简要总结

Obesity is a chronic disease in which accumulation of excess body fat can result in impaired health. In cases of severe obesity, weight loss surgery can be necessary as a treatment. There are different forms of surgery but the common basic principle is to restrict food intake and decrease the absorption of food in the stomach and intestines. As a consequence, there is a higher risk of developing nutrient deficiency after surgery and supplementation of protein, vitamins, and minerals can be necessary. This study evaluates intakes of protein, vitamins, and minerals in patients with weight loss surgery and compares them to recommended intakes. Further, this study looks at the role of age, sex, and socioeconomic status in this context.

详细描述

Obesity is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. These days, bariatric surgery is considered the most effective treatment of morbid obesity. In the last decade, the number of bariatric surgeries performed worldwide constantly increased. Common bariatric surgery procedures include gastric bypass, sleeve gastrectomy, adjustable gastric band, and biliopancreatic diversion with duodenal switch. After surgery, weight loss is induced by a reduced food volume the stomach can hold, malabsorption of nutrients, or by a combination of both mechanisms. In consequence, patients with bariatric surgery have an increased risk of developing nutrient deficiency. Therefore, guidelines recommend supplementation of critical nutrients, i.e. protein, vitamins, and minerals, after bariatric surgery. This study assesses intake of these nutrients in patients with bariatric surgery based on the recommendations provided by the German S3 Guideline Group on the Surgical Treatment of Obesity and Metabolic Diseases. In particular, this study assesses the association of therapy adherence with age, sex, and socioeconomic status.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Sleeve gastrectomy (postoperative)
  • Roux-en-Y gastric Bypass (postoperative)
  • Postoperative period > 6 month

排除标准

  • Missing consent
  • Pregnancy
  • Malignant tumor
  • Implanted pacemaker
  • Any other serious primary disease

结局指标

主要结局

Therapy Adherence Across Groups of Socio-Economic Status

时间窗: Baseline

Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.

次要结局

  • Body Weight(Baseline)
  • Waist Circumference(Baseline)
  • Total Body Water(Baseline)
  • Diastolic Blood Pressure(Baseline)
  • Therapy Adherence Across Age Groups(Baseline)
  • Body Height(Baseline)
  • Therapy Adherence Across Sexes(Baseline)
  • Improvement of Deficiency Symptoms(Baseline)
  • Body Mass Index(Baseline)
  • Hip Circumference(Baseline)
  • Waist-to-Hip Ratio(Baseline)
  • Triceps Skinfold Thickness(Baseline)
  • Upper Arm Circumference(Baseline)
  • Phase Angle(Baseline)
  • Systolic Blood Pressure(Baseline)
  • Energy Intake(Baseline)
  • Protein Intake(Baseline)
  • Fat Intake(Baseline)
  • Omega-6 Fatty Acid Intake(Baseline)
  • Dietary Fiber Intake(Baseline)
  • Fat Free Mass(Baseline)
  • Fat Mass(Baseline)
  • Skeletal Muscle Mass(Baseline)
  • Extracellular Water(Baseline)
  • Muscle Strength(Baseline)
  • Physical Activity(Baseline)
  • Carbohydrate Intake(Baseline)
  • Omega-3 Fatty Acid Intake(Baseline)
  • Sucrose Intake(Baseline)
  • Alcohol Intake(Baseline)
  • Diet Quality(Baseline)
  • Quality of Life Assessment(Baseline)
  • Intestinal Microbiome(Baseline)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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