Type 2 Diabetes MellitusNCT02625649
Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients
An observational study of Type 2 Diabetes Mellitus and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Diabetic Retinopathy
- How many people
- 148 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jun 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Cases: Type 2 diabetes mellitus patients living in Central Denmark region that have undergone Roux-en-Y gastric bapass between 2006-2011. Controls: Type 2 diabetes mellitus patients living in Central Denmark region, non-RYGB-operated
Who may be able to join
- Capable
- type 2 diabetes mellitus
- speaks and understands Danish
- presents written concent
- cases must be Roux-en-Y operated between 2006-2011.
Who cannot join
- Converted Roux-en-Y
- chronic inflammatory bowel disease
- ischemic heart disease
- liver disease
- cholecystectomy.
- Controls can not be bariatric operated.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients: Register-based and Clinical Follow-up Studies
This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular complications such as nephropathy and retinopathy. Finally, the study provides insight into the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota diversity and bile acid levels.
Read the detailed description
One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM patients, matched on gender, age, presurgical body mass index, and diabetes duration.
The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire.
More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part of the patients.
- Keywords
- Roux-en-Y gastric bypass, obesity, type 2 diabetes mellitus, diabetic nephropathy, diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetic Retinopathy, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RYGB | RYGB-operated type 2 diabetic patients | |
| non-RYGB | non-RYGB-operated type 2 diabetic controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with HbA1c<48 mmol/mol.
Measured: Maximum follow-up is 121 months (january 2006-february 2016)
Secondary outcomes (3)
Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry
Measured: Maximum follow-up is 121 months (january 2006-february 2016)
Number of patients with urine albumin/creatinin< 30 mg/g
Measured: Maximum follow-up is 121 months (january 2006-february 2016)
Number of patients with two-step change from preoperative level on the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) scale
Measured: From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene R Madsen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625649
- Sponsor's protocol ID
- 11092015
- Status last verified
- Oct 2016
- First submitted
- 30 Nov 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Madsen LR, Bek T, Richelsen B. Diabetic retinopathy in people with Type 2 diabetes and obesity treated by Roux-en-Y gastric bypass compared with non-operated controls: with focus on the role of diabetes remission in a cross-sectional and a 6-year follow-up study. Diabet Med. 2019 Apr;36(4):457-464. doi: 10.1111/dme.13876. Epub 2018 Dec 26.
PubMed 30537170
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients: Register-based and Clinical Follow-up Studies
- ClinicalTrials.gov ID
- NCT02625649
- Acronym / sponsor ID
- 11092015
- Keywords
- Roux-en-Y gastric bypass, obesity, type 2 diabetes mellitus, diabetic nephropathy, diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Dec 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.
This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular complications such as nephropathy and retinopathy. Finally, the study provides insight into the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota diversity and bile acid levels.
Detailed description
One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM patients, matched on gender, age, presurgical body mass index, and diabetes duration.
The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire.
More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB | – | –RYGB-operated type 2 diabetic patients |
| non-RYGB | – | –non-RYGB-operated type 2 diabetic controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cases: Type 2 diabetes mellitus patients living in Central Denmark region that have undergone Roux-en-Y gastric bapass between 2006-2011. Controls: Type 2 diabetes mellitus patients living in Central Denmark region, non-RYGB-operated
Key inclusion criteria (5 listed)
- Capable
- type 2 diabetes mellitus
- speaks and understands Danish
- presents written concent
- cases must be Roux-en-Y operated between 2006-2011.
Key exclusion criteria (6 listed)
- Converted Roux-en-Y
- chronic inflammatory bowel disease
- ischemic heart disease
- liver disease
- cholecystectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with HbA1c<48 mmol/mol.
Time frame: Maximum follow-up is 121 months (january 2006-february 2016)
3 secondary outcomes
Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry
Time frame: Maximum follow-up is 121 months (january 2006-february 2016)
Number of patients with urine albumin/creatinin< 30 mg/g
Time frame: Maximum follow-up is 121 months (january 2006-february 2016)
Number of patients with two-step change from preoperative level on the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) scale
Time frame: From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months
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 26 Jun 2017.
- Derived from this study: PubMed 30537170Madsen LR, Bek T, Richelsen B. Diabetic retinopathy in people with Type 2 diabetes and obesity treated by Roux-en-Y gastric bypass compared with non-operated controls: with focus on the role of diabetes remission in a cross-sectional and a 6-year follow-up study. Diabet Med. 2019 Apr;36(4):457-464. doi: 10.1111/dme.13876. Epub 2018 Dec 26.
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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.
Lene R Madsen, MD principal investigator
Aarhus University Hospital
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 Type 2 Diabetes Mellitus and Obesity, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 6 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 26 Jun 2017. 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 Denmark. 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?
Number of patients with HbA1c<48 mmol/mol. (time frame: Maximum follow-up is 121 months (january 2006-february 2016)). 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 NCT02625649, which also lists 1 linked publication.
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 26 Jun 2017.