Long-term Results After Bariatric Surgery in Type 1 Diabetes Patients

Completed

• Conditions: Bariatric Surgery Status in T1D

• Registration Number: NCT06394479
• Lead Sponsor: Sana Klinikum Offenbach

Brief Summary

There is a lack of long-term data on the impact of bariatric surgery in type 1 diabetes (T1D). The aim of this study is to gain long-term outcome data on the effects of bariatric surgery in obese patients with T1D.

Detailed Description

This study aims to evaluate long-term data on the effect of bariatric surgery in T1D regarding weight lost, insulin-requirement, and quality of life.

Inclusion criteria are patients who underwent bariatric surgery (Sleeve, One anastomosis gastric bypass, Roux en Y Gastric Bypass) and the presence of T1D prior to surgery. Labor parameters include verification of T1D antibodies, and level of C-peptide. Exclusion criteria is T2D.

In order to obtain a sufficient number of patients for the evaluation, several sites are involved in the acquisition of these specific data.

Study Timeline

• Study Start: 2019-12-06
• Study First Submitted: 2019-12-06
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• T1D-specific antibodies
• C-peptide level
• status after bariatric surgery

Exclusion Criteria

• T2D
• patients without T1D
• patients with T1d without bariatric surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-surgical impact on body weight	1 year	Body weight in kgpost-surgical A1c course

Secondary Outcome Measures

Name	Time	Method
Post-surgical impact on metabolic changes	1 year	insulin-requirement in I.U.
Post-surgical impact on body weight and metabolic changes	1 year	insulin-requirement per kg/BW

Trial Locations

Locations (1)

Sana obesity center; 🇩🇪 Remscheid, Germany