Type 2 DiabetesNCT01993511
Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass
An observational study of Type 2 Diabetes and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. However the mechanisms for this improvement remain uncertain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Jun 2014
- 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
- Healthy volunteers accepted
- Adult
Study population: Morbid obese patients who are already enrolled for Roux-en-y gastric bypass surgery will be invited to participate (investigators do not assign patients to the surgery). 8 with type 2 diabetes, 8 with impaired glucose tolerance and 8 with normal glucose tolerance. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) prior to surgery and prior to the other tests. Plasma glucose 120 minutes after OGTT will define glucose tolerance. Normal: < 7,8 mM. Impaired: 7,8 - 11,1 mM. Diabetic: >11,1 mM. Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital.
Who may be able to join
- patients eligible for RYGB, Age 18-60 years, BMI 35-60 kg/m2 at time of referral to operation, blood pressure <145/85, C-peptid>700 pmol/l.
Who cannot join
- Obesity caused by medical treatment for psychiatric disease. Mental retardation. Alcohol or drug abuse. Severe cardiopulmonary disease. History of peritonitis, ventricular disease, upper gastrointestinal surgery, recurrent oesophagitis or severe complications to general anesthesia. Bad compliance. Treatment with thyroid hormones or antithyroid treatment. Treatment with anorectic medicine later than 3 months prior to surgery. Furthermore prior to surgery each patient has to loose 8 % of bodyweight to reduce the risk of operative complications.
- Before each test day all glucose lowering medication will be paused for an appropriate amount of time depending on the type of medicine.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Anna Kirstine Bojsen-Møller, MD, +45 30 25 22 06, kirstine.bojsen-moeller@regionh.dk
Anna Kirstine Bojsen-Møller, MD
About this study
Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. However the mechanisms for this improvement remain uncertain. The aim of this study is to investigate the changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB using oral and intravenous test.
Read the detailed description
Investigators plan to study 24 obese patients already enrolled for Roux-en-y gastric bypass surgery (RYGB). 8 with type 2 diabetes (DM2), 8 with impaired glucose tolerance (IGT) and 8 with normal glucose tolerance (NGT) before, within the first week and 3 month after RYGB using a liquid mixed meal test (MMT) and an insulin modified frequently sampled intravenous glucose tolerance test (IM-FSIGT). Furthermore, an oral glucose tolerance test (OGTT) will be performed before and after 3 months. Blood will be sampled in fasting and during the tests measuring plasma glucose, insulin and C-peptid (OGTT, MMT and IM-FSIGT) and GLP-1, glucagon, GIP and GLP-2 (MMT). Beta-cell function will be assessed from the MMT (insulinogenic index - IGI), OGTT (IGI) and the IM-FSIGT (Acute insulin response, AIR) in order to examine whether changes in beta-cell function after RYGB depend on an oral stimulus. Insulin sensitivity will be assessed in fasting (HOMA-IR), during the IM-FSIGT (minimal model: Si) and from MMT/OGTT (Matsuda index). Insulin clearance/hepatic extraction of insulin will be assessed in fasting and during the intravenous and oral test.
- Conditions
- Type 2 Diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
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 patients with type 2 diabetes | Preoperative oral glucose tolerance test with 2 h P-glucose >11.1 mmol/L | |
| RYGB patients with IGT | Preoperative oral glucose tolerance test with 2 h p-glucose >7.8 and <11.1 mmol/L | |
| RYGB patients with NGT | Preoperative oral glucose tolerance test with 2 h p-Glucose <7.8 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta-cell function after RYGB.
Beta-cell function will be assessed with both intravenous tests (acute insulin response to glucose - AIRg) and oral tests (insulinogenic index - IGI).
Measured: 1 week and 3 months.
Secondary outcomes (1)
Change in insulin sensitivity after RYGB.
Insulin sensitivity will be assessed in fasting and by intravenous tests (sensitivity index - Si) and oral tests (Matsuda index).
Measured: 1 week and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital
- Investigators
- Anna Kirstine Bojsen-Moeller, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993511
- Sponsor's protocol ID
- SHJNBJ-FX10
- Status last verified
- Nov 2013
- First submitted
- 12 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M; New Collective Author. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.
PubMed 27306058Martinussen C, Bojsen-Moller KN, Dirksen C, Jacobsen SH, Jorgensen NB, Kristiansen VB, Holst JJ, Madsbad S. Immediate enhancement of first-phase insulin secretion and unchanged glucose effectiveness in patients with type 2 diabetes after Roux-en-Y gastric bypass. Am J Physiol Endocrinol Metab. 2015 Mar 15;308(6):E535-44. doi: 10.1152/ajpendo.00506.2014. Epub 2015 Jan 27.
PubMed 25628424
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01993511
- Acronym / sponsor ID
- SHJNBJ-FX10
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Nov 2013 (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.
Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. However the mechanisms for this improvement remain uncertain. The aim of this study is to investigate the changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB using oral and intravenous test.
Detailed description
Investigators plan to study 24 obese patients already enrolled for Roux-en-y gastric bypass surgery (RYGB). 8 with type 2 diabetes (DM2), 8 with impaired glucose tolerance (IGT) and 8 with normal glucose tolerance (NGT) before, within the first week and 3 month after RYGB using a liquid mixed meal test (MMT) and an insulin modified frequently sampled intravenous glucose tolerance test (IM-FSIGT). Furthermore, an oral glucose tolerance test (OGTT) will be performed before and after 3 months. Blood will be sampled in fasting and during the tests measuring plasma glucose, insulin and C-peptid (OGTT, MMT and IM-FSIGT) and GLP-1, glucagon, GIP and GLP-2 (MMT). Beta-cell function will be assessed from the MMT (insulinogenic index - IGI), OGTT (IGI) and the IM-FSIGT (Acute insulin response, AIR) in order to examine whether changes in beta-cell function after RYGB depend on an oral stimulus. Insulin sensitivity will be assessed in fasting (HOMA-IR), during the IM-FSIGT (minimal model: Si) and from MMT/OGTT (Matsuda index). Insulin clearance/hepatic extraction of insulin will be assessed in fasting and during the intravenous and oral test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RYGB patients with type 2 diabetes | – | –Preoperative oral glucose tolerance test with 2 h P-glucose >11.1 mmol/L |
| RYGB patients with IGT | – | –Preoperative oral glucose tolerance test with 2 h p-glucose >7.8 and <11.1 mmol/L |
| RYGB patients with NGT | – | –Preoperative oral glucose tolerance test with 2 h p-Glucose <7.8 mmol/L |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Morbid obese patients who are already enrolled for Roux-en-y gastric bypass surgery will be invited to participate (investigators do not assign patients to the surgery). 8 with type 2 diabetes, 8 with impaired glucose tolerance and 8 with normal glucose tolerance. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) prior to surgery and prior to the other tests. Plasma glucose 120 minutes after OGTT will define glucose tolerance. Normal: < 7,8 mM. Impaired: 7,8 - 11,1 mM. Diabetic: >11,1 mM. Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital.
Key inclusion criteria (1 listed)
- patients eligible for RYGB, Age 18-60 years, BMI 35-60 kg/m2 at time of referral to operation, blood pressure <145/85, C-peptid>700 pmol/l.
Key exclusion criteria (2 listed)
- Obesity caused by medical treatment for psychiatric disease. Mental retardation. Alcohol or drug abuse. Severe cardiopulmonary disease. History of peritonitis, ventricular disease, upper gastrointestinal surgery, recurrent oesophagitis or severe complications to general anesthesia. Bad compliance. Treatment with thyroid hormones or antithyroid treatment. Treatment with anorectic medicine later than 3 months prior to surgery. Furthermore prior to surgery each patient has to loose 8 % of bodyweight to reduce the risk of operative complications.
- Before each test day all glucose lowering medication will be paused for an appropriate amount of time depending on the type of medicine.
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
Change in beta-cell function after RYGB.
Time frame: 1 week and 3 months.
Beta-cell function will be assessed with both intravenous tests (acute insulin response to glucose - AIRg) and oral tests (insulinogenic index - IGI).
1 secondary outcome
Change in insulin sensitivity after RYGB.
Time frame: 1 week and 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 27306058Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M; New Collective Author. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.
- Derived from this study: PubMed 25628424Martinussen C, Bojsen-Moller KN, Dirksen C, Jacobsen SH, Jorgensen NB, Kristiansen VB, Holst JJ, Madsbad S. Immediate enhancement of first-phase insulin secretion and unchanged glucose effectiveness in patients with type 2 diabetes after Roux-en-Y gastric bypass. Am J Physiol Endocrinol Metab. 2015 Mar 15;308(6):E535-44. doi: 10.1152/ajpendo.00506.2014. Epub 2015 Jan 27.
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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.
Anna Kirstine Bojsen-Moeller, MD principal investigator
Hvidovre 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 and Obesity, run by Hvidovre University Hospital 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 1 inclusion and 2 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 25 Nov 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Kirstine Bojsen-Møller, MD (+45 30 25 22 06, kirstine.bojsen-moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in beta-cell function after RYGB. (time frame: 1 week and 3 months.). 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 NCT01993511, which also lists 2 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 25 Nov 2013.