Diabetes Mellitus, Type 2Phase 1/2NCT03182231
GLP1-imaging Before and After Bariatric Surgery
A Phase 1/2 study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Bariatric Surgery Candidate
- What is being tested?
- 68Ga-NODAGA-exendin-4 PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 Oct 2016to 1 Jul 2023
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbid obese T2D patient who will have RYGB at the Rijnstate in Arnhem
- Female
- Signed informed consent
- Mild T2D:
- C-peptide > 1.0 nmol/L
- Only metformin usage as anti-diabetic medication
Show all 9Show fewer
- Progressive T2D:
- C-peptide < 1.0 nmol/L
- Insulin and/or sulfonylurea (SU) usage
Who cannot join
- Fasting glucose < 6 at time C-peptide was determined
- Liver failure
- BMI > 50 kg/m-2
- Previous treatment with synthetic exendin
- Pregnancy
- Breast feeding
Show all 9Show fewer
- Kidney failure
- Age < 18 years
- No signed informed consent
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate hospital
Arnhem
Laura Deden, MSc, l.deden@rijnstate.nl
- Recruiting
Radboudumc
Nijmegen, 6500HB
Marti Boss, Msc, +312436 ext. 67243, marti.boss@radboudumc.nl
About this study
Official title: Visualizing Beta Cells in Patients With T2D Before and After Bariatric Surgery
In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data will provide investigators with more information on the contribution of the beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the prognostic value of pre-operative beta cell mass determination to T2D resolution. This might be of great interest for the assessment of RYGB as an alternative therapy in patients with T2D and a BMI <35, who currently do not meet the international guidelines for bariatric surgery.
Read the detailed description
The prevalence of Type 2 Diabetes Mellitus (T2D) in the Netherlands is 600.000-800.000 and each year ~70.000 new patients are diagnosed. This increasing number of patients with T2D is closely correlated with the obesity epidemic.
Obese patients with T2D are also at risk to develop dyslipidemia and hypertension. This clustering of cardiovascular risk factors leads to an increased risk of micro-and macrovascular long-term complications. In fact, patients with T2D have a 2-4 times increased risk for cardiovascular disease. These complications seriously decrease the quality of life and life expectancy of T2D patients. The burden of this disease affects our society as well. Health care costs with respect to diabetes amounted 814 million euro in 2005 in the Netherlands and indirect costs because of absence of work are unknown but thought to be substantial.
Weight loss is perhaps the most important therapeutic intervention in obese patients with T2D. Weight loss intervenes in the underlying pathophysiology and restores insulin sensitivity and sometimes even insulin secretion. In addition, it improves dyslipidemia and hypertension. In contrast, most pharmacological interventions only relieve the symptoms of the complex disease process underlying T2D whilst the disease process itself is not addressed and even progresses in the course of time. Unfortunately, the effect of weight loss interventions such as diet and lifestyle or even drugs (orlistat, sibutramine) is often modest (3-5 kg) and short-lived.
Bariatric surgery and T2D remission Weight reducing surgery, i.e. bariatric surgery, is the only intervention that leads to persistent weight loss and is superior above conventional (non-surgical) treatment. Bariatric surgery can be divided into restrictive (gastric band or sleeve) and malabsorptive (biliopancreatic diversion, BD) procedures or a combination of both (Roux-en-Y gastric bypass, RYGB). Currently, RYGB is the most performed bariatric procedure. The international indications for bariatric surgery are BMI > 40kg/m2 or BMI > 35 kg/m2 with co-morbidities (e.g. T2D).
Besides weight loss, spectacular metabolic improvements after bariatric surgery are seen. In patients with T2D, normalization of fasting plasma glucose and/or HbA1c without medication (referred as "resolution of T2D") was observed in 48% and 83% after gastric banding and RYGB, respectively. Recently, randomized controlled trials showed the superiority of bariatric surgery in glycemic control above conventional medical treatment. Furthermore, the improvement in glycemic control is higher in RYGB compared to purely restrictive bariatric procedures.
The mechanism of diabetes resolution after RYGB is not completely understood and there is evidence that it might not be dependent on weight loss only. Improvements in glycemic control have been found within days after surgery, while significant weight loss has not yet been achieved at this time. There are several hypotheses concerning the weight-independent effects of bariatric surgery on insulin secretion. The most popular are the 'hindgut-hypothesis', which states that expedited delivery of nutrients to the distal intestine enhances the secretion of intestinal peptides like glucagon-like-peptide 1 (GLP1) and peptide YY and the 'foregut hypothesis', which states that the exclusion of the duodenum and proximal jejunum from the transit of nutrients results in changes in secretion of intestinal peptides. However, several other mechanisms, both in- and outside the intestines might play a role.
The beta cell function improves after RYGB in individuals with and without T2D, however it is unclear whether the actual beta cell mass is subject to change after bariatric surgery. Examination of the beta cell mass on autopsy specimens of persons who did not have bariatric surgery, showed a decrease in beta cell mass in persons with T2D in one of the studies a decrease was found in persons with pre-diabetes as well.
Few studies were performed that assessed beta cell mass after bariatric surgery. In Goto-Kakizaki rats duodenal jejunal bypass was found to increase pancreatic concentrations of vesicular monoamine transporter type 2 (VMAT2). VMAT2 was used as a biomarker for beta cells, however later VMAT2 was found to be expressed on pancreatic polypeptide cells (PP cells) as well. Furthermore, an increase in beta cell mass, beta cell number and extra islet beta cells was found after RYGB in a porcine model and GK rat model. Studies in humans showed conflicting results. Long term after gastric bypass, cases of hyperinsulinemic hypoglycemia have been described, which are related to pancreatic islet hyperplasia or nesidioblastosis, while this does not occur after purely restrictive surgery. However, beta cell mass was assessed in six patients after gastric bypass by histological analysis of the pancreas after pancreatectomy and did not find an increase in beta cell mass. These studies were performed on pancreas specimen and not in vivo.
The benefit of RYGB on glycemic control in morbid obese patients (BMI > 35 kg/m2) with T2D is confirmed and the Diabetes Surgery Summit Consensus Conference accepted bariatric surgery as alternative therapy of obesity related T2D. They also consider expanding the indication for bariatric surgery in obese patients with T2D who currently don't meet the international guidelines for bariatric surgery. In this regard it would be helpful to identify preoperatively which T2D patients would benefit from RYGB. Prognostic factors that were described previously are the duration of diabetes, age, preoperatively HbA1c levels and fasting C-peptide. However, the underlying cause of T2D resolution and the prognostic value of these factors are not completely understood. Possibly, T2D resolution depends on the preoperative available beta cell mass and function and increased beta cell failure or reduced beta cell ass might decrease the chance of T2D resolution. Therefore, more information on the effects of bariatric surgery on beta cell function and beta cell mass will be helpful to further understand T2D resolution and the role of the beta cells. Thereby, preoperative beta cell mass might be a prognostic factor of T2D resolution and helpful in identifying obese T2D patients that will benefit from RYGB and expanding the indications for bariatric surgery for those patients. For this purpose reliable, sensitive and specific visualization of living pancreatic beta cells in vivo is important.
GLP-1 receptor imaging by PET For specific non-invasive imaging of beta cells, we have developed a highly beta cell-specific radiolabeled exendin-based GLP-1 analog which, after radiolabeling, can non-invasively be detected in the human body. GLP-1 is an incretin hormone that specifically binds to beta cells and is responsible for post-prandial insulin-secretion. Its specificity for beta cells has been shown and a linear correlation of the beta cell mass and the signal obtained with this tracer has been established.
GLP-1R imaging has been shown to be suitable for imaging of insulin producing pancreatic neuroendocrine tumours (IPPNET). Furthermore, the feasibility of visualization of transplanted beta cells with GLP-1R imaging has been shown by imaging of autologous islets transplanted into muscle.
- Being tested
- 68Ga-NODAGA-exendin-4 PET/CT
- Keywords
- exendin, GLP1, beta cell mass
- 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.
68Ga-NODAGA-exendin-4 PET/CTRadiation
68Ga-NODAGA-exendin-4 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| RYGB patients | Experimental | Patients who will receive a RYGB surgery Receives: Radiation: 68Ga-NODAGA-exendin-4 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Change in tracer uptake before and after RYGB
Measured: 4 years
Secondary outcomes (2)
T2D outcome
Comparison of tracer uptake with T2D outcome
Measured: after 1 year
Beta cell function
Correlation between tracer uptake and beta cell function
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start7 Oct 2016
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Patients will receive an 68Ga-NODAGA-exendin-4 PET/CT scan before RYGB and 1 year after RYGB
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182231
- Sponsor's protocol ID
- NL51980.091.15
- Status last verified
- Jun 2021
- First submitted
- 29 May 2017
- Last updated
- 21 Jun 2022
- 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing Beta Cells in Patients With T2D Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03182231
- Acronym / sponsor ID
- NL51980.091.15
- Keywords
- exendin, GLP1, beta cell mass
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 Jun 2017 (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.
In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data will provide investigators with more information on the contribution of the beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the prognostic value of pre-operative beta cell mass determination to T2D resolution. This might be of great interest for the assessment of RYGB as an alternative therapy in patients with T2D and a BMI <35, who currently do not meet the international guidelines for bariatric surgery.
Detailed description
The prevalence of Type 2 Diabetes Mellitus (T2D) in the Netherlands is 600.000-800.000 and each year ~70.000 new patients are diagnosed. This increasing number of patients with T2D is closely correlated with the obesity epidemic.
Obese patients with T2D are also at risk to develop dyslipidemia and hypertension. This clustering of cardiovascular risk factors leads to an increased risk of micro-and macrovascular long-term complications. In fact, patients with T2D have a 2-4 times increased risk for cardiovascular disease. These complications seriously decrease the quality of life and life expectancy of T2D patients. The burden of this disease affects our society as well. Health care costs with respect to diabetes amounted 814 million euro in 2005 in the Netherlands and indirect costs because of absence of work are unknown but thought to be substantial.
Weight loss is perhaps the most important therapeutic intervention in obese patients with T2D. Weight loss intervenes in the underlying pathophysiology and restores insulin sensitivity and sometimes even insulin secretion. In addition, it improves dyslipidemia and hypertension. In contrast, most pharmacological interventions only relieve the symptoms of the complex disease process underlying T2D whilst the disease process itself is not addressed and even progresses in the course of time. Unfortunately, the effect of weight loss interventions such as diet and lifestyle or even drugs (orlistat, sibutramine) is often modest (3-5 kg) and short-lived.
Bariatric surgery and T2D remission Weight reducing surgery, i.e. bariatric surgery, is the only intervention that leads to persistent weight loss and is superior above conventional (non-surgical) treatment. Bariatric surgery can be divided into restrictive (gastric band or sleeve) and malabsorptive (biliopancreatic diversion, BD) procedures or a combination of both (Roux-en-Y gastric bypass, RYGB). Currently, RYGB is the most performed bariatric procedure. The international indications for bariatric surgery are BMI > 40kg/m2 or BMI > 35 kg/m2 with co-morbidities (e.g. T2D).
Besides weight loss, spectacular metabolic improvements after bariatric surgery are seen. In patients with T2D, normalization of fasting plasma glucose and/or HbA1c without medication (referred as "resolution of T2D") was observed in 48% and 83% after gastric banding and RYGB, respectively. Recently, randomized controlled trials showed the superiority of bariatric surgery in glycemic control above conventional medical treatment. Furthermore, the improvement in glycemic control is higher in RYGB compared to purely restrictive bariatric procedures.
The mechanism of diabetes resolution after RYGB is not completely understood and there is evidence that it might not be dependent on weight loss only. Improvements in glycemic control have been found within days after surgery, while significant weight loss has not yet been achieved at this time. There are several hypotheses concerning the weight-independent effects of bariatric surgery on insulin secretion. The most popular are the 'hindgut-hypothesis', which states that expedited delivery of nutrients to the distal intestine enhances the secretion of intestinal peptides like glucagon-like-peptide 1 (GLP1) and peptide YY and the 'foregut hypothesis', which states that the exclusion of the duodenum and proximal jejunum from the transit of nutrients results in changes in secretion of intestinal peptides. However, several other mechanisms, both in- and outside the intestines might play a role.
The beta cell function improves after RYGB in individuals with and without T2D, however it is unclear whether the actual beta cell mass is subject to change after bariatric surgery. Examination of the beta cell mass on autopsy specimens of persons who did not have bariatric surgery, showed a decrease in beta cell mass in persons with T2D in one of the studies a decrease was found in persons with pre-diabetes as well.
Few studies were performed that assessed beta cell mass after bariatric surgery. In Goto-Kakizaki rats duodenal jejunal bypass was found to increase pancreatic concentrations of vesicular monoamine transporter type 2 (VMAT2). VMAT2 was used as a biomarker for beta cells, however later VMAT2 was found to be expressed on pancreatic polypeptide cells (PP cells) as well. Furthermore, an increase in beta cell mass, beta cell number and extra islet beta cells was found after RYGB in a porcine model and GK rat model. Studies in humans showed conflicting results. Long term after gastric bypass, cases of hyperinsulinemic hypoglycemia have been described, which are related to pancreatic islet hyperplasia or nesidioblastosis, while this does not occur after purely restrictive surgery. However, beta cell mass was assessed in six patients after gastric bypass by histological analysis of the pancreas after pancreatectomy and did not find an increase in beta cell mass. These studies were performed on pancreas specimen and not in vivo.
The benefit of RYGB on glycemic control in morbid obese patients (BMI > 35 kg/m2) with T2D is confirmed and the Diabetes Surgery Summit Consensus Conference accepted bariatric surgery as alternative therapy of obesity related T2D. They also consider expanding the indication for bariatric surgery in obese patients with T2D who currently don't meet the international guidelines for bariatric surgery. In this regard it would be helpful to identify preoperatively which T2D patients would benefit from RYGB. Prognostic factors that were described previously are the duration of diabetes, age, preoperatively HbA1c levels and fasting C-peptide. However, the underlying cause of T2D resolution and the prognostic value of these factors are not completely understood. Possibly, T2D resolution depends on the preoperative available beta cell mass and function and increased beta cell failure or reduced beta cell ass might decrease the chance of T2D resolution. Therefore, more information on the effects of bariatric surgery on beta cell function and beta cell mass will be helpful to further understand T2D resolution and the role of the beta cells. Thereby, preoperative beta cell mass might be a prognostic factor of T2D resolution and helpful in identifying obese T2D patients that will benefit from RYGB and expanding the indications for bariatric surgery for those patients. For this purpose reliable, sensitive and specific visualization of living pancreatic beta cells in vivo is important.
GLP-1 receptor imaging by PET For specific non-invasive imaging of beta cells, we have developed a highly beta cell-specific radiolabeled exendin-based GLP-1 analog which, after radiolabeling, can non-invasively be detected in the human body. GLP-1 is an incretin hormone that specifically binds to beta cells and is responsible for post-prandial insulin-secretion. Its specificity for beta cells has been shown and a linear correlation of the beta cell mass and the signal obtained with this tracer has been established.
GLP-1R imaging has been shown to be suitable for imaging of insulin producing pancreatic neuroendocrine tumours (IPPNET). Furthermore, the feasibility of visualization of transplanted beta cells with GLP-1R imaging has been shown by imaging of autologous islets transplanted into muscle.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive an 68Ga-NODAGA-exendin-4 PET/CT scan before RYGB and 1 year after RYGB
| Arm | Type | Receives |
|---|---|---|
| RYGB patients | Experimental | Radiation: 68Ga-NODAGA-exendin-4 PET/CTPatients who will receive a RYGB surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Morbid obese T2D patient who will have RYGB at the Rijnstate in Arnhem
- Female
- Signed informed consent
- C-peptide > 1.0 nmol/L
- Only metformin usage as anti-diabetic medication
Key exclusion criteria (9 listed)
- Fasting glucose < 6 at time C-peptide was determined
- Liver failure
- BMI > 50 kg/m-2
- Previous treatment with synthetic exendin
- Pregnancy
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 |
|---|---|---|
| 68Ga-NODAGA-exendin-4 PET/CT68Ga-NODAGA-exendin-4 PET/CT | Radiation | RYGB patients |
Primary outcome
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Time frame: 4 years
Change in tracer uptake before and after RYGB
2 secondary outcomes
T2D outcome
Time frame: after 1 year
Beta cell function
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, run by Radboud University Medical Center at 2 sites in Netherlands.
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 9 inclusion and 9 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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic uptake of 68Ga-NODAGA-exendin-4 (time frame: 4 years). 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 Jun 2022.