Type I DiabetesNCT02612493
Obesity and Metabolic Surgery in Patients With Type I Diabetes
An observational study of Type I Diabetes, run by Sana Klinikum Offenbach.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Obese patients with type I diabetes
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Nov 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All obeses patients with type I diabetes who underwent weight loss surgery in our department.
Who may be able to join
- type I diabetes
- BMI > 40kg/m2
Who cannot join
- type II diabetes
About this study
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.
Read the detailed description
The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.
- Conditions
- Type I Diabetes
- Being tested
- Obese patients with type I diabetes
- Keywords
- obesity surgery, type I diabetes, weight loss, insulin dosage, postsurgery metabolic changes
- Medical subject headings
- Diabetes Mellitus, Type 1, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obese patients with type I diabetesOther
Postsurgical follow - up in obese patients with type I diabetes
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin dosage
Insulin dosage postsurgery
Measured: up to 8 years
Secondary outcomes (3)
Excess Weight loss in %
Measured: up to 8 years
Change in HgA1c
Measured: up to 8 years
Change in lipids
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startJan 2006
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type I DiabetesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Stier, Sana Klinikum Offenbach
- Investigators
- Rudolf Weiner, MD, Prof., Study chair, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612493
- Sponsor's protocol ID
- FF 120/2015
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23834044Kirwan 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.
PubMed 25342846Brethauer 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.
PubMed 24558084
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Metabolic Surgery in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT02612493
- Acronym / sponsor ID
- FF 120/2015
- Conditions
- Type I Diabetes
- Keywords
- obesity surgery, type I diabetes, weight loss, insulin dosage, postsurgery metabolic changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
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.
Detailed description
The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All obeses patients with type I diabetes who underwent weight loss surgery in our department.
Key inclusion criteria (2 listed)
- type I diabetes
- BMI > 40kg/m2
Key exclusion criteria (1 listed)
- type II diabetes
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 |
|---|---|---|
| Obese patients with type I diabetesPostsurgical follow - up in obese patients with type I diabetes | Other | – |
Primary outcome
Insulin dosage
Time frame: up to 8 years
Insulin dosage postsurgery
3 secondary outcomes
Excess Weight loss in %
Time frame: up to 8 years
Change in HgA1c
Time frame: up to 8 years
Change in lipids
Time frame: up to 8 years
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 23 Nov 2015.
- Results publication: PubMed 23834044Raab 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.
- Results publication: PubMed 25342846Kirwan 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.
- Results publication: PubMed 24558084Brethauer 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.
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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.
Rudolf Weiner, MD, Prof. study chair
Sana Klinikum Offenbach
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes, run by Sana Klinikum Offenbach.
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 2 inclusion and 1 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 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Insulin dosage (time frame: up to 8 years). 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 NCT02612493, which also lists 3 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 23 Nov 2015.