Type2 DiabetesBETASINNCT04782999
Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes
A study testing Oral Glucose Tolerance Test and Hyperglycemic clamp with infusion of saline, GLP-1 or GIP in people with Type2 Diabetes and Obesity, Morbid, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes, Obesity, Morbid
- What is being tested?
- Oral Glucose Tolerance Test and Hyperglycemic clamp with infusion of saline, GLP-1 or GIP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Mar 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for RYGB in Denmark (ie. BMI > 35 in the presence of obesity related co-morbidities as type 2 diabetes)
- Type 2 diabetes
- Pre-operative: Fasting plasma glucose ≥7,0 mmol/L or 2 hour plasma glucose ≥ 11,1 mmol/L (after pausing antidiabetic medication for a minimum of 3 days)
- Written informed consent.
Who cannot join
- Exclusion criteria for RYGB (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance).
- Type 2 diabetes where antidiabetic medication cannot be paused for 3 days.
- Pregnancy and breast-feeding.
- Hemoglobin <7.0 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes.
Primary hypotheses:
- After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect).
- After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively.
- After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.
Read the detailed description
Design: 12 patients with type 2 diabetes will be recruited.
All subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperatively:
- Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be performed before and 3 months post-surgery.
- Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.
- Conditions
- Type2 Diabetes, Obesity, Morbid
- Being tested
- Oral Glucose Tolerance Test, Hyperglycemic clamp with infusion of saline, GLP-1 or GIP
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic test
Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.
Hyperglycemic clamp with infusion of saline, GLP-1 or GIPDiagnostic test
Blood glucose kept at 15 mmol/L via iv 20% glucose infusions.
Primed co-infusion of either:
- Saline
- GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min)
- GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min).
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose tolerance test | Active comparator | Oral glucose tolerance test with ingestion of 75 g glucose and blood sampling.
This test will be performed before and 3 months after RYGB. Receives: Diagnostic Test: Oral Glucose Tolerance Test |
| Hyperglycemic clamp with saline infusion combined with arginine test | Active comparator | Hyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusions of intraveneous glucose for 120 min with co-infusion of saline.
After 120 min an arginine test with infusion of 50 g Arginine is performed.
This test will be performed before, 1 week and 3 months after RYGB. Receives: Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIP |
| Hyperglycemic clamp with GLP-1 infusion | Active comparator | Hyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusion of intraveneous glucose for 90 min with co-infusion of GLP-1.
This test will be performed before, 1 week and 3 months after RYGB. Receives: Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIP |
| Hyperglycemic clamp with GIP infusion | Active comparator | Hyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusions of intraveneous glucose for 90 minutes with co-infusion of GIP.
This test will be performed before, 1 week and 3 months after RYGB. Receives: Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulinotropic effects of GLP-1 and GIP
Insulin secretion during steady state of all hyperglycemic clamps
Measured: Change from before to 1 week and 3 months after RYGB
Insulin secretion during oral stimulation
AUC of C-peptide during oral glucose tolerance test
Measured: Change from before to 3 month after RYGB
Insulin secretion during iv stimulation
Insulin secretion during hyperglycemic clamp with saline infusion and during argininine iv stimulation test
Measured: Change from before to 1 week and 3 months after RYGB
Secondary outcomes (1)
Alpha cell function
Glucagon secretion during hyperglycemic clamps
Measured: Change from before to after 1 week and 3 months after RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study startJan 2015
- Primary completionJan 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Randomised
- Intervention model
- Single group
- Model description
- Prospective evaluation of gastric bypass patients, who will be examined before, 1 week and 3 months after the gastric bypass operation.
- 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
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Maria Saur Svane, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782999
- Sponsor's protocol ID
- H-7-2014-010
- Acronym
- BETASIN
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04782999
- Acronym / sponsor ID
- BETASIN / H-7-2014-010
- Conditions
- Type2 Diabetes, Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 4 Mar 2021 (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.
The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes.
Primary hypotheses:
- After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect).
- After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively.
- After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.
Detailed description
Design: 12 patients with type 2 diabetes will be recruited.
All subjects will undergo 11 study visits: four visits before, three visits at 1 week after surgery and four visits at 3 months postoperatively:
- Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be performed before and 3 months post-surgery.
- Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a randomised order at three separate study visits in randomized order before, 1 week and 3 months after surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Prospective evaluation of gastric bypass patients, who will be examined before, 1 week and 3 months after the gastric bypass operation.
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test | Active comparator | Diagnostic Test: Oral Glucose Tolerance TestOral glucose tolerance test with ingestion of 75 g glucose and blood sampling. This test will be performed before and 3 months after RYGB. |
| Hyperglycemic clamp with saline infusion combined with arginine test | Active comparator | Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIPHyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusions of intraveneous glucose for 120 min with co-infusion of saline. After 120 min an arginine test with infusion of 50 g Arginine is performed. This test will be performed before, 1 week and 3 months after RYGB. |
| Hyperglycemic clamp with GLP-1 infusion | Active comparator | Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIPHyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusion of intraveneous glucose for 90 min with co-infusion of GLP-1. This test will be performed before, 1 week and 3 months after RYGB. |
| Hyperglycemic clamp with GIP infusion | Active comparator | Diagnostic Test: Hyperglycemic clamp with infusion of saline, GLP-1 or GIPHyperglycemic clamp with blood glucose kept at 15 mmol/L by adjustable infusions of intraveneous glucose for 90 minutes with co-infusion of GIP. This test will be performed before, 1 week and 3 months after RYGB. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inclusion criteria for RYGB in Denmark (ie. BMI > 35 in the presence of obesity related co-morbidities as type 2 diabetes)
- Type 2 diabetes
- Pre-operative: Fasting plasma glucose ≥7,0 mmol/L or 2 hour plasma glucose ≥ 11,1 mmol/L (after pausing antidiabetic medication for a minimum of 3 days)
- Written informed consent.
Key exclusion criteria (4 listed)
- Exclusion criteria for RYGB (psychiatric illness, obesity triggered by medical treatment for psychiatric illness, mental retardation, alcohol or drug abuse, severe heart-lung disease despite optimal medical treatment, previous serious problems with universal anesthesia, previous peritonitis, large hiatus hernia, diseases of the ventricle / previously complicated upper abdominal surgery, recurrent esophagitis, poor compliance).
- Type 2 diabetes where antidiabetic medication cannot be paused for 3 days.
- Pregnancy and breast-feeding.
- Hemoglobin <7.0 mmol/L
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 |
|---|---|---|
| Oral Glucose Tolerance TestStandard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling. | Diagnostic test | Oral glucose tolerance test |
| Hyperglycemic clamp with infusion of saline, GLP-1 or GIPBlood glucose kept at 15 mmol/L via iv 20% glucose infusions. Primed co-infusion of either: * Saline * GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min) * GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min). | Diagnostic test | Hyperglycemic clamp with GIP infusion, Hyperglycemic clamp with GLP-1 infusion, Hyperglycemic clamp with saline infusion combined with arginine test |
Primary outcome
Insulinotropic effects of GLP-1 and GIP
Time frame: Change from before to 1 week and 3 months after RYGB
Insulin secretion during steady state of all hyperglycemic clamps
Insulin secretion during oral stimulation
Time frame: Change from before to 3 month after RYGB
AUC of C-peptide during oral glucose tolerance test
Insulin secretion during iv stimulation
Time frame: Change from before to 1 week and 3 months after RYGB
Insulin secretion during hyperglycemic clamp with saline infusion and during argininine iv stimulation test
1 secondary outcome
Alpha cell function
Time frame: Change from before to after 1 week and 3 months after RYGB
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 16 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test and Hyperglycemic clamp with infusion of saline, GLP-1 or GIP in people with Type2 Diabetes and Obesity, Morbid, 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 4 inclusion and 4 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 16 Mar 2022. 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?
Insulinotropic effects of GLP-1 and GIP (time frame: Change from before to 1 week and 3 months after RYGB). The study lists 3 primary outcomes in all. 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 16 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.