Prospective study for the clinical evaluation of fat-soluble vitamins (ADEK) after obesity surgery (Roux-Y stomach bypass, tube stomach)

Prospective study for the clinical evaluation of fat-soluble vitamins (ADEK) after obesity surgery (Roux-Y stomach bypass, tube stomach) - adiADEK

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013992

Enrollment

100

Registered

2018-02-15

Start date

2018-02-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66

Interventions

Group 1: There is a group of patients. The vitamin content of all participants is measured during the operation and then at regular intervals. The measurement is carried out once after the operation o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Applicable study participants are all patients who have received reimbursement from the health insurance company after MDK examination and thus meet the strict inclusion criteria according to the current S3 guideline for obesity surgery.

Exclusion criteria

Exclusion criteria: - Pregnancy - lack of own ability to give consent - Participation in a clinical trial within the last 4 weeks prior to and during the trial

Design outcomes

Primary

Measure	Time frame
Measurements: For each order, the following patient data is collected in a pseudonymised form. 1. BIA (bioimpedance analysis) measurement with Seca scale type mBCA 515 with all evaluation parameters 2. blood sampling a. standard laboratory b. Vitamins A, D, E, K, RBP c. Adipokine biomarkers (including leptin, RBP4, etc.) Additionally during the operation: 1. removal of subcutaneous fat 2. removal of visceral fat 3. removal of liver tissue 4. sample from removed tissue (gastrointestinal tract) The following parameters are determined for tissue samples: 1. vitamin A 2. RBP 3. adipokine biomarkers (including leptin, RBP4, etc.) Measuring times: T-1 Discussion and examination 14 days to 3 weeks before scheduled surgery T 0 Operation date: 1 day before standard laboratory T 1 Discussion and examination 4 weeks after surgery T 2 Discussion and examination 3 months after surgery T 3 Discussion and examination 6 months after surgery T 4 Discussion and examination 9 months after surgery T 5 Discussion and examination 12 months after surgery	—

Measure

Time frame

Measurements: For each order, the following patient data is collected in a pseudonymised form. 1. BIA (bioimpedance analysis) measurement with Seca scale type mBCA 515 with all evaluation parameters 2. blood sampling a. standard laboratory b. Vitamins A, D, E, K, RBP c. Adipokine biomarkers (including leptin, RBP4, etc.) Additionally during the operation: 1. removal of subcutaneous fat 2. removal of visceral fat 3. removal of liver tissue 4. sample from removed tissue (gastrointestinal tract) The following parameters are determined for tissue samples: 1. vitamin A 2. RBP 3. adipokine biomarkers (including leptin, RBP4, etc.) Measuring times: T-1 Discussion and examination 14 days to 3 weeks before scheduled surgery T 0 Operation date: 1 day before standard laboratory T 1 Discussion and examination 4 weeks after surgery T 2 Discussion and examination 3 months after surgery T 3 Discussion and examination 6 months after surgery T 4 Discussion and examination 9 months after surgery T 5 Discussion and examination 12 months after surgery

—

Countries

Germany

Contacts

Public ContactMatthias C. Raggi

Chefarzt für Allgemein- und ViszeralchirurgieAdipositaszentrum Stuttgart Sana Klinik Bethesda Stuttgart

matthias.raggi@sana.de+49 711 2156-441

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026