NCT04587076

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 7, 2020

Last Update Submit

October 7, 2020

Conditions

Keywords

Gastric BypassGastric Sleeve

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Faeces

MeSH Terms

Conditions

KwashiorkorAvitaminosisObesityObesity, Morbid

Condition Hierarchy (Ancestors)

Severe Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDeficiency DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Dr. med. Markus M. Lerch

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

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

Locations