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

NCT06394479 | Completed

• 1 other identifier: FF120/2015
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Status in T1D

Outcome Measures

Primary Outcomes (1)

• Post-surgical impact on body weight

  Body weight in kgpost-surgical A1c course

  1 year

Secondary Outcomes (2)

• Post-surgical impact on metabolic changes

  1 year

• Post-surgical impact on body weight and metabolic changes

  1 year

Interventions

Outcome after bariatric surgery in patient with T1D OTHER

Retrospective evaluation of clinical data

Also known as: Metabolic changes after bariatric surgery in T1D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients with T1D, who underwent bariatric surgery

You may qualify if:

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

You may not qualify if:

• T2D
• patients without T1D
• patients with T1d without bariatric surgery

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead
• SRH Wald-Klinikum Gera GmbH: collaborator
• Wuerzburg University Hospital: collaborator
• Kuwait University: collaborator
• Cleveland Clinic Florida: collaborator

Study Sites (1)

Sana obesity center

Remscheid, 42859, Germany

Location

Related Publications (13)

• 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.

  PMID: 27222552 BACKGROUND

• 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.

  PMID: 24274980 BACKGROUND

• 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.

  PMID: 15480539 BACKGROUND

• 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.

  PMID: 25061146 BACKGROUND

• 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.

  PMID: 26087341 BACKGROUND

• 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.

  PMID: 25413942 BACKGROUND

• 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.

  PMID: 30060120 BACKGROUND

• 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.

  PMID: 26452482 BACKGROUND

• 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.

  PMID: 26694210 BACKGROUND

• 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.

  PMID: 28836234 BACKGROUND

• 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.

  PMID: 29641734 BACKGROUND

• 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.

  PMID: 30911264 BACKGROUND

• 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.

  PMID: 30728940 BACKGROUND

Study Officials

• Christine Stier, MD

  Sana Klinikum Offenbach

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: May 1, 2024
• Study Start: December 6, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 28, 2020
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

DE (1)