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NCT02612493 Clinical Trial

Obesity and Metabolic Surgery in Patients With Type I Diabetes

Type I Diabetes Clinical Trial

Official title:
Obesity and Metabolic Surgery in Patients With Type I Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02612493
Other study ID # FF 120/2015
Secondary ID
Status Completed
Phase N/A
First received November 17, 2015
Last updated November 20, 2015
Start date January 2006
Est. completion date November 2015

Study information
Verified date November 2015
Source Sana Klinikum Offenbach
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- type I diabetes

- BMI > 40kg/m2

Exclusion Criteria:

- type II diabetes

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Obese patients with type I diabetes
Postsurgical follow - up in obese patients with type I diabetes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sana Klinikum Offenbach

References & Publications (3)

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. — View Citation

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 Ca — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin dosage Insulin dosage postsurgery up to 8 years Yes
Secondary Excess Weight loss in % up to 8 years Yes
Secondary Change in HgA1c up to 8 years Yes
Secondary Change in lipids up to 8 years Yes
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