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OpenTrials
Completed

NCT Number: NCT06394479

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

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.

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Key information

Conditions

Bariatric Surgery Status in T1D

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sana obesity center

Remscheid, 42859, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Outcome after bariatric surgery in patient with T1D

Other

Retrospective evaluation of clinical data

Other names: Metabolic changes after bariatric surgery in T1D

Primary outcomes

  1. Post-surgical impact on body weight

    Time frame: 1 year

    Body weight in kgpost-surgical A1c course

Secondary outcomes

  1. Post-surgical impact on metabolic changes

    Time frame: 1 year

    insulin-requirement in I.U.

  2. Post-surgical impact on body weight and metabolic changes

    Time frame: 1 year

    insulin-requirement per kg/BW

Sponsors and collaborators

Lead sponsor

Sana Klinikum Offenbach

Other

Collaborators

  • Cleveland Clinic Florida
  • Kuwait University
  • SRH Wald-Klinikum Gera GmbH
  • Wuerzburg University Hospital

Registry information

Official study title

Evaluation of the Long-term Outcome After Bariatric Surgery in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.