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

NCT ID: NCT06394479

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-06

Study Completion Date

2020-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Status in T1D

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Outcome after bariatric surgery in patient with T1D

Retrospective evaluation of clinical data

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Metabolic changes after bariatric surgery in T1D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* T1D-specific antibodies
* C-peptide level
* status after bariatric surgery

Exclusion Criteria

* T2D
* patients without T1D
* patients with T1d without bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SRH Wald-Klinikum Gera GmbH

OTHER

Sponsor Role collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role collaborator

Kuwait University

OTHER

Sponsor Role collaborator

Cleveland Clinic Florida

OTHER

Sponsor Role collaborator

Sana Klinikum Offenbach

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christine Stier

Study coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine Stier, MD

Role: STUDY_DIRECTOR

Sana Klinikum Offenbach

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sana obesity center

Remscheid, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Kirwan JP, Aminian A, Kashyap SR, Burguera B, Brethauer SA, Schauer PR. Bariatric Surgery in Obese Patients With Type 1 Diabetes. Diabetes Care. 2016 Jun;39(6):941-8. doi: 10.2337/dc15-2732.

Reference Type BACKGROUND
PMID: 27222552 (View on PubMed)

Chillaron JJ, Flores Le-Roux JA, Benaiges D, Pedro-Botet J. Type 1 diabetes, metabolic syndrome and cardiovascular risk. Metabolism. 2014 Feb;63(2):181-7. doi: 10.1016/j.metabol.2013.10.002. Epub 2013 Oct 24.

Reference Type BACKGROUND
PMID: 24274980 (View on PubMed)

Fourlanos S, Narendran P, Byrnes GB, Colman PG, Harrison LC. Insulin resistance is a risk factor for progression to type 1 diabetes. Diabetologia. 2004 Oct;47(10):1661-7. doi: 10.1007/s00125-004-1507-3. Epub 2004 Oct 6.

Reference Type BACKGROUND
PMID: 15480539 (View on PubMed)

Lannoo M, Dillemans B, Van Nieuwenhove Y, Fieuws S, Mathieu C, Gillard P, D'Hoore A, Van Der Schueren B. Bariatric surgery induces weight loss but does not improve glycemic control in patients with type 1 diabetes. Diabetes Care. 2014 Aug;37(8):e173-4. doi: 10.2337/dc14-0583. No abstract available.

Reference Type BACKGROUND
PMID: 25061146 (View on PubMed)

Polsky S, Ellis SL. Obesity, insulin resistance, and type 1 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2015 Aug;22(4):277-82. doi: 10.1097/MED.0000000000000170.

Reference Type BACKGROUND
PMID: 26087341 (View on PubMed)

Chillaron JJ, Benaiges D, Mane L, Pedro-Botet J, Flores Le-Roux JA. Obesity and type 1 diabetes mellitus management. Minerva Endocrinol. 2015 Mar;40(1):53-60. Epub 2014 Nov 21.

Reference Type BACKGROUND
PMID: 25413942 (View on PubMed)

Corbin KD, Driscoll KA, Pratley RE, Smith SR, Maahs DM, Mayer-Davis EJ; Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON). Obesity in Type 1 Diabetes: Pathophysiology, Clinical Impact, and Mechanisms. Endocr Rev. 2018 Oct 1;39(5):629-663. doi: 10.1210/er.2017-00191.

Reference Type BACKGROUND
PMID: 30060120 (View on PubMed)

Mahawar KK, De Alwis N, Carr WR, Jennings N, Schroeder N, Small PK. Bariatric Surgery in Type 1 Diabetes Mellitus: A Systematic Review. Obes Surg. 2016 Jan;26(1):196-204. doi: 10.1007/s11695-015-1924-z.

Reference Type BACKGROUND
PMID: 26452482 (View on PubMed)

Ashrafian H, Harling L, Toma T, Athanasiou C, Nikiteas N, Efthimiou E, Darzi A, Athanasiou T. Type 1 Diabetes Mellitus and Bariatric Surgery: A Systematic Review and Meta-Analysis. Obes Surg. 2016 Aug;26(8):1697-704. doi: 10.1007/s11695-015-1999-6.

Reference Type BACKGROUND
PMID: 26694210 (View on PubMed)

Mottalib A, Kasetty M, Mar JY, Elseaidy T, Ashrafzadeh S, Hamdy O. Weight Management in Patients with Type 1 Diabetes and Obesity. Curr Diab Rep. 2017 Aug 23;17(10):92. doi: 10.1007/s11892-017-0918-8.

Reference Type BACKGROUND
PMID: 28836234 (View on PubMed)

Hussain A. The effect of metabolic surgery on type 1 diabetes: meta-analysis. Arch Endocrinol Metab. 2018 Apr 5;62(2):172-178. doi: 10.20945/2359-3997000000021. Print 2018 Mar-Apr.

Reference Type BACKGROUND
PMID: 29641734 (View on PubMed)

Akcay MN, Karadeniz E, Ahiskalioglu A. Bariatric/Metabolic Surgery in Type 1 and Type 2 Diabetes Mellitus. Eurasian J Med. 2019 Feb;51(1):85-89. doi: 10.5152/eurasianjmed.2018.18298.

Reference Type BACKGROUND
PMID: 30911264 (View on PubMed)

Landau Z, Kowen-Sandbank G, Jakubowicz D, Raziel A, Sakran N, Zaslavsky-Paltiel I, Lerner-Geva L, Pinhas-Hamiel O. Bariatric surgery in patients with type 1 diabetes: special considerations are warranted. Ther Adv Endocrinol Metab. 2019 Jan 30;10:2042018818822207. doi: 10.1177/2042018818822207. eCollection 2019.

Reference Type BACKGROUND
PMID: 30728940 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FF120/2015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.