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Clinical Trials/NCT04587076
NCT04587076
Completed
N/A

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 site in 1 country38 target enrollmentJuly 3, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Protein Malnutrition
Sponsor
University Medicine Greifswald
Enrollment
38
Locations
1
Primary Endpoint
Therapy Adherence Across Groups of Socio-Economic Status
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2019
End Date
September 30, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Therapy Adherence Across Groups of Socio-Economic Status

Time Frame: Baseline

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

Secondary Outcomes

  • 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)

Study Sites (1)

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