Obesity and Metabolic Surgery in Patients With Type I Diabetes

November 20, 2015 updated by: Christine Stier, Sana Klinikum Offenbach
Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery the patients improve remarkable in their need for insulin, not only in the daily total insulin dosage but also in the dosage of IU per kg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.

Study Type

Observational

Enrollment (Actual)

16

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All obeses patients with type I diabetes who underwent weight loss surgery in our department.

Description

Inclusion Criteria:

  • type I diabetes
  • BMI > 40kg/m2

Exclusion Criteria:

  • type II diabetes

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin dosage
Time Frame: up to 8 years
Insulin dosage postsurgery
up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Excess Weight loss in %
Time Frame: up to 8 years
up to 8 years
Change in HgA1c
Time Frame: up to 8 years
up to 8 years
Change in lipids
Time Frame: up to 8 years
up to 8 years

Collaborators and Investigators

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

Sponsor

Sana Klinikum Offenbach

Investigators

  • Study Chair: Rudolf Weiner, MD, Prof., 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

January 1, 2006

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 120/2015

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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