Bariatric Surgery Status in T1DNCT06394479
Long-term Results After Bariatric Surgery in Type 1 Diabetes Patients
An observational study of Bariatric Surgery Status in T1D, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bariatric Surgery Status in T1D
- What is being tested?
- Outcome after bariatric surgery in patient with T1D
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2019to 28 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with T1D, who underwent bariatric surgery
Who may be able to join
- T1D-specific antibodies
- C-peptide level
- status after bariatric surgery
Who cannot join
- T2D
- patients without T1D
- patients with T1d without bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Long-term Outcome After Bariatric Surgery in Patients With Type 1 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Bariatric Surgery Status in T1D
- Being tested
- Outcome after bariatric surgery in patient with T1D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome after bariatric surgery in patient with T1DOther
Also called Metabolic changes after bariatric surgery in T1D
Retrospective evaluation of clinical data
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical impact on body weight
Body weight in kgpost-surgical A1c course
Measured: 1 year
Secondary outcomes (2)
Post-surgical impact on metabolic changes
insulin-requirement in I.U.
Measured: 1 year
Post-surgical impact on body weight and metabolic changes
insulin-requirement per kg/BW
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start6 Dec 2019
- Primary completion28 Feb 2020
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery Status in T1DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Collaborators
- SRH Wald-Klinikum Gera GmbH, Wuerzburg University Hospital, Kuwait University, Cleveland Clinic Florida
- Responsible party
- Principal investigator, Christine Stier, Sana Klinikum Offenbach
- Investigators
- Christine Stier, MD, Study director, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394479
- Sponsor's protocol ID
- FF120/2015
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2019
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27222552Chillaron 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.
PubMed 24274980Fourlanos 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.
PubMed 15480539Lannoo 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.
PubMed 25061146Polsky 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.
PubMed 26087341Chillaron 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.
PubMed 25413942Corbin 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.
PubMed 30060120Mahawar 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.
PubMed 26452482Ashrafian 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.
PubMed 26694210Mottalib 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.
PubMed 28836234Hussain 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.
PubMed 29641734Akcay 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.
PubMed 30911264Landau 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.
PubMed 30728940
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Outcome After Bariatric Surgery in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06394479
- Acronym / sponsor ID
- FF120/2015
- Conditions
- Bariatric Surgery Status in T1D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Collaborators
- SRH Wald-Klinikum Gera GmbH, Wuerzburg University Hospital, Kuwait University, Cleveland Clinic Florida
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with T1D, who underwent bariatric surgery
Key inclusion criteria (3 listed)
- T1D-specific antibodies
- C-peptide level
- status after bariatric surgery
Key exclusion criteria (3 listed)
- T2D
- patients without T1D
- patients with T1d without bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outcome after bariatric surgery in patient with T1DAlso: Metabolic changes after bariatric surgery in T1DRetrospective evaluation of clinical data | Other | – |
Primary outcome
Post-surgical impact on body weight
Time frame: 1 year
Body weight in kgpost-surgical A1c course
2 secondary outcomes
Post-surgical impact on metabolic changes
Time frame: 1 year
Post-surgical impact on body weight and metabolic changes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 27222552Kirwan 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.
- Background: PubMed 24274980Chillaron 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.
- Background: PubMed 15480539Fourlanos 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.
- Background: PubMed 25061146Lannoo 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.
- Background: PubMed 26087341Polsky 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.
- Background: PubMed 25413942Chillaron 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.
- Background: PubMed 30060120Corbin 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.
- Background: PubMed 26452482Mahawar 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.
- Background: PubMed 26694210Ashrafian 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.
- Background: PubMed 28836234Mottalib 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.
- Background: PubMed 29641734Hussain 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.
- Background: PubMed 30911264Akcay 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Stier, MD study director
Sana Klinikum Offenbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Status in T1D, run by Sana Klinikum Offenbach at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical impact on body weight (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394479, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.