Type 2 DiabetesNCT01579981
The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects
A study testing Roux-en-Y Gastric Bypass in people with Type 2 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Roux-en-Y Gastric Bypass
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Nov 2012
- Phase
- Interventional
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting glucose > 7.0 mM, 2h glucose after OGTT > 11.0 mM. BMI > 35. HbA1c < 8.5%. Fasting C-peptide > 700 pM. Elegible for RYGB.
Who cannot join
- Dysregulated hypothyroidism, hyperthyroidism, anaemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Exaggerated Glucagon-like Peptide-1 Response is Important for the Improved β-cell Function and Glucose Tolerance After Roux-en-Y Gastric Bypass in Patients With Type 2 Diabetes
After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined
Read the detailed description
After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined
- Conditions
- Type 2 Diabetes
- Being tested
- Roux-en-Y Gastric Bypass
- Keywords
- RYGB, Bariatric Surgery, Glucagon-like-peptide 1
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric BypassProcedure or surgery
On two separate experimental days before, 1 wk, and 3 months after RYGB, subjects are given a liquid meal test during Exendin 9-39 (900 pmol/min/kg)or saline infusion. The order of the infusions is randomized. At end of study day an ad libitum meal is served.
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta cell glucose sensitivity
change in prehepatic insulin secretionrate relative to glucose increments
Measured: 1 week and 3 months after RYGB
Secondary outcomes (2)
Glucose tolerance
change in AUC glucose
Measured: 1 week and 3 months after RYGB
Ad libitum food intake
Change in amount of calories ingested
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Bruun Jørgensen, Hvidovre University Hospital
- Investigators
- Sten Madsbad, MD, DMSc, Study chair, Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, DenmarkNils B Jørgensen, MD, Principal investigator, Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579981
- Sponsor's protocol ID
- H-A-2008-080-31742
- Status last verified
- Feb 2017
- First submitted
- 16 Apr 2012
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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 27306058Lindegaard KK, Jorgensen NB, Just R, Heegaard PM, Madsbad S. Effects of Roux-en-Y gastric bypass on fasting and postprandial inflammation-related parameters in obese subjects with normal glucose tolerance and in obese subjects with type 2 diabetes. Diabetol Metab Syndr. 2015 Feb 24;7:12. doi: 10.1186/s13098-015-0012-9. eCollection 2015.
PubMed 25763111
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exaggerated Glucagon-like Peptide-1 Response is Important for the Improved β-cell Function and Glucose Tolerance After Roux-en-Y Gastric Bypass in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01579981
- Acronym / sponsor ID
- H-A-2008-080-31742
- Conditions
- Type 2 Diabetes
- Keywords
- RYGB, Bariatric Surgery, Glucagon-like-peptide 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Apr 2012 (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.
After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined
Detailed description
After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting glucose > 7.0 mM, 2h glucose after OGTT > 11.0 mM. BMI > 35. HbA1c < 8.5%. Fasting C-peptide > 700 pM. Elegible for RYGB.
Key exclusion criteria (1 listed)
- Dysregulated hypothyroidism, hyperthyroidism, anaemia.
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 |
|---|---|---|
| Roux-en-Y Gastric BypassOn two separate experimental days before, 1 wk, and 3 months after RYGB, subjects are given a liquid meal test during Exendin 9-39 (900 pmol/min/kg)or saline infusion. The order of the infusions is randomized. At end of study day an ad libitum meal is served. | Procedure or surgery | – |
Primary outcome
Beta cell glucose sensitivity
Time frame: 1 week and 3 months after RYGB
change in prehepatic insulin secretionrate relative to glucose increments
2 secondary outcomes
Glucose tolerance
Time frame: 1 week and 3 months after RYGB
Ad libitum food intake
Time frame: 3 months after surgery
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 10 Feb 2017.
- 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 25763111Lindegaard KK, Jorgensen NB, Just R, Heegaard PM, Madsbad S. Effects of Roux-en-Y gastric bypass on fasting and postprandial inflammation-related parameters in obese subjects with normal glucose tolerance and in obese subjects with type 2 diabetes. Diabetol Metab Syndr. 2015 Feb 24;7:12. doi: 10.1186/s13098-015-0012-9. eCollection 2015.
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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.
Sten Madsbad, MD, DMSc study chair
Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
Nils B Jørgensen, MD principal investigator
Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass in people with Type 2 Diabetes, 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 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 10 Feb 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?
Beta cell glucose sensitivity (time frame: 1 week and 3 months after RYGB). 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 NCT01579981, 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 10 Feb 2017.