Continuous Glucose MonitoringNCT04172116
Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass
An observational study of Continuous Glucose Monitoring and Roux-en-y Gastric Bypass, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Continuous Glucose Monitoring, Roux-en-y Gastric Bypass, Hypoglycemia
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2020to Jan 2021
- 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: Of each bariatric-metabolic operation we plan to include 34 patients. Of these 34 patients we plan to include also patients in each group with a diagnosed Diabetes mellitus type II at the time of operation (defined by either HbA1c >6.5 or any medication or impaired fasting blood glucose level) 1. Roux-en-y gastric bypass with long ang narrow pouch ("long pouch RYGB") 2. Roux-en-y gastric bypass with short and broad pouch ("short pouch RYGB") Patients in the two RYGB groups will be matched for sex, age, comorbidities and BMI at the time of operation.
Who may be able to join
- Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the "long and narrow" pouch group
- Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the "short and wide" pouch group
- Patients on oral medication for diabetes mellitus (for subgroup assessment)
- Stable weight (not more than + 15kg from lowest weight postoperatively)
- Stable BMI
Who cannot join
- Unable to give written informed consent
- Patients with methods other than RYGB
- Reoperation within the observed period
- Any intervention changing pouch size or diameter of the anastomosis after the initial operation
- Known allergy to oral contrast agent
- Any regular intake of medication interfering with blood glucose levels
Trial locations and contacts
1 site in 1 country.
Austria1 site
Landesklinikum Weinviertel Hollabrunn
Hollabrunn, 2020
Phillip Beckerhinn, MD, chirurgie@hollabrunn.lknoe.at
Franz Hoffer, MD, chirurgie@hollabrunn.lknoe.at
About this study
Official title: Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass: Comparing Tissue Glucose Levels Between Two Surgical Bypass Methods - a Prospective Study
This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.
- Being tested
- Continuous glucose monitoring
- Keywords
- metabolic surgery
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| long pouch RYGB | Patients with the variation of a long and narrow pouch (hypothesis: slower transit of food) Receives: Device: Continuous glucose monitoring | |
| short pouch RYGB | Patients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch) Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue glucose levels
Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass
Measured: 6 days
Secondary outcomes (1)
tissue vs. blood glucose levels
Comparison of tissue and blood glucose levels
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Gerhard Prager, Medical University of Vienna
- Investigators
- Gerhard Prager, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172116
- Sponsor's protocol ID
- 2235/2018
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass: Comparing Tissue Glucose Levels Between Two Surgical Bypass Methods - a Prospective Study
- ClinicalTrials.gov ID
- NCT04172116
- Acronym / sponsor ID
- 2235/2018
- Keywords
- metabolic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 21 Nov 2019 (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.
This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long pouch RYGB | – | Device: Continuous glucose monitoringPatients with the variation of a long and narrow pouch (hypothesis: slower transit of food) |
| short pouch RYGB | – | Device: Continuous glucose monitoringPatients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Of each bariatric-metabolic operation we plan to include 34 patients. Of these 34 patients we plan to include also patients in each group with a diagnosed Diabetes mellitus type II at the time of operation (defined by either HbA1c >6.5 or any medication or impaired fasting blood glucose level) 1. Roux-en-y gastric bypass with long ang narrow pouch ("long pouch RYGB") 2. Roux-en-y gastric bypass with short and broad pouch ("short pouch RYGB") Patients in the two RYGB groups will be matched for sex, age, comorbidities and BMI at the time of operation.
Key inclusion criteria (5 listed)
- Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the "long and narrow" pouch group
- Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the "short and wide" pouch group
- Patients on oral medication for diabetes mellitus (for subgroup assessment)
- Stable weight (not more than + 15kg from lowest weight postoperatively)
- Stable BMI
Key exclusion criteria (6 listed)
- Unable to give written informed consent
- Patients with methods other than RYGB
- Reoperation within the observed period
- Any intervention changing pouch size or diameter of the anastomosis after the initial operation
- Known allergy to oral contrast agent
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 |
|---|---|---|
| Continuous glucose monitoringsee arm/group descriptions | Device | long pouch RYGB, short pouch RYGB |
Primary outcome
Tissue glucose levels
Time frame: 6 days
Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass
1 secondary outcome
tissue vs. blood glucose levels
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Gerhard Prager, MD principal investigator
Medical University of Vienna
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 Continuous Glucose Monitoring and Roux-en-y Gastric Bypass, run by Medical University of Vienna at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 21 Nov 2019. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Prager, MD (0043 40400 56210, gerhard.prager@muw.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue glucose levels (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2019.