Clinical trial NCT06394479: Long-term Results After Bariatric Surgery in Type 1 Diabetes Patients
Official title: Evaluation of the Long-term Outcome After Bariatric Surgery in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Status in T1D
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
Collaborators: name: SRH Wald-Klinikum Gera GmbH
name: Wuerzburg University Hospital
name: Kuwait University
name: Cleveland Clinic Florida
First posted: 2024-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with T1D, who underwent bariatric surgery

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Post-surgical impact on body weight
timeFrame: 1 year
Secondary outcomes:
measure: Post-surgical impact on metabolic changes
timeFrame: 1 year
measure: Post-surgical impact on body weight and metabolic changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Remscheid
country: Germany
facility: Sana obesity center
Study officials:
affiliation: Sana Klinikum Offenbach
name: Christine Stier, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.