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CompletedNCT02612493Updated Nov 23, 2015

Obesity and Metabolic Surgery in Patients With Type I Diabetes

An observational study in Type I Diabetes, sponsored by Sana Klinikum Offenbach. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Sana Klinikum Offenbach · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
16
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Type I Diabetes

Keywords

  • obesity surgery
  • type I diabetes
  • weight loss
  • insulin dosage
  • postsurgery metabolic changes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 16 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sana Klinikum Offenbach is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • type I diabetes
  • BMI > 40kg/m2

Exclusion criteria

Exclusion Criteria:

  • type II diabetes
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
16 participants (actual)
Patient registry
No

Interventions

  • OtherObese patients with type I diabetes

    Postsurgical follow - up in obese patients with type I diabetes

06

What researchers measure

Primary outcomes

  1. Insulin dosage

    Insulin dosage postsurgery

    Time frame: up to 8 years

Secondary outcomes

  1. Excess Weight loss in %

    Time frame: up to 8 years

  2. Change in HgA1c

    Time frame: up to 8 years

  3. Change in lipids

    Time frame: up to 8 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Raab H, Weiner RA, Frenken M, Rett K, Weiner S. Obesity and metabolic surgery in type 1 diabetes mellitus. Nutr Hosp. 2013 Mar;28 Suppl 2:31-4. doi: 10.3305/nh.2013.28.sup2.6711. PubMed 23834044 ↗
  • Kirwan JP, Brethauer SA, Aminian A, Rosenthal RJ, Kashyap SR, Schauer PR. Response to comments on Brethauer et al. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes care 2014;37:e51-e52. Diabetes Care. 2014 Nov;37(11):e251. doi: 10.2337/dc14-1769. No abstract available. PubMed 25342846 ↗
  • Brethauer SA, Aminian A, Rosenthal RJ, Kirwan JP, Kashyap SR, Schauer PR. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes Care. 2014;37(3):e51-2. doi: 10.2337/dc13-1736. No abstract available. PubMed 24558084 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02612493
Lead sponsor
Sana Klinikum Offenbach
Responsible party
Christine Stier (MD, PhD, Sana Klinikum Offenbach) — Principal investigator
First posted
Nov 23, 2015
Start date
Jan 2006
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Nov 23, 2015

Study contacts

Rudolf Weiner, MD, Prof.
study chair · Sana Klinikum Offenbach

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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