NCT02612493

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

9.8 years

First QC Date

November 17, 2015

Last Update Submit

November 20, 2015

Conditions

Type I Diabetes

Keywords

obesity surgerytype I diabetesweight lossinsulin dosagepostsurgery metabolic changes

Outcome Measures

Primary Outcomes (1)

  • Insulin dosage

    Insulin dosage postsurgery

    up to 8 years

Secondary Outcomes (3)

  • Excess Weight loss in %

    up to 8 years

  • Change in HgA1c

    up to 8 years

  • Change in lipids

    up to 8 years

Interventions

Obese patients with type I diabetesOTHER

Postsurgical follow - up in obese patients with type I diabetes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • type I diabetes
  • BMI \> 40kg/m2

You may not qualify if:

  • type II diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23834044RESULT

  • 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.

    PMID: 25342846RESULT

  • 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.

    PMID: 24558084RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Weight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rudolf Weiner, MD, Prof.

    Sana Klinikum Offenbach

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 23, 2015

Study Start

January 1, 2006

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 23, 2015

Record last verified: 2015-11