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

April 27, 2024 updated by: Christine Stier, Sana Klinikum Offenbach

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Remscheid, Germany, 42859
        • Sana obesity center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese patients with T1D, who underwent bariatric surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical impact on body weight
Time Frame: 1 year
Body weight in kgpost-surgical A1c course
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical impact on metabolic changes
Time Frame: 1 year
insulin-requirement in I.U.
1 year
Post-surgical impact on body weight and metabolic changes
Time Frame: 1 year
insulin-requirement per kg/BW
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Collaborators

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

Investigators

  • Study Director: Christine Stier, MD, Sana Klinikum Offenbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

March 28, 2020

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF120/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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