Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery
BOP
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?
1 other identifier
observational
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedOctober 14, 2020
October 1, 2020
3 months
October 7, 2020
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapy Adherence Across Groups of Socio-Economic Status
Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.
Baseline
Secondary Outcomes (33)
Therapy Adherence Across Age Groups
Baseline
Therapy Adherence Across Sexes
Baseline
Improvement of Deficiency Symptoms
Baseline
Body Weight
Baseline
Body Height
Baseline
- +28 more secondary outcomes
Eligibility Criteria
Patients were recruited at University Medicine Greifswald, a medical center with expertise in obesity Treatment located in Northeast Germany. Patients meeting the study's eligibilty criteria who attended their routine postoperative care visits after bariatric surgery were approached for study participation.
You may qualify if:
- Sleeve gastrectomy (postoperative)
- Roux-en-Y gastric Bypass (postoperative)
- Postoperative period \> 6 month
You may not qualify if:
- Missing consent
- Pregnancy
- Malignant tumor
- Implanted pacemaker
- Any other serious primary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medicine Greifswald
Greifswald, Germany
Biospecimen
Faeces
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Dr. med. Markus M. Lerch
University Medicine Greifswald
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 14, 2020
Study Start
July 3, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 14, 2020
Record last verified: 2020-10