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Gestational DiabetesNCT03182296

Visualizing Beta Cells in Patients With a History of Gestational Diabetes

A study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Gestational Diabetes, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In order to evaluate the difference in beta cell mass in women with and without a history of gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of the pancreas between these groups. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
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
24 participants
Where
1 siteNetherlands
Study dates
10 Nov 2016to 1 Jan 2026
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnancy with diagnosis of GDM, within the last 5 years
  • No other previous pregnancies
  • Complete resolution of GDM after delivery
  • No evidence of T2D at the time of inclusion
  • BMI between 17 and 30
  • Signed informed consent
Show all 12Show fewer
  • Pregnancy without problems in glucose homeostasis, within the last 5 years
  • No other previous pregnancies
  • No evidence of T2D at time of inclusion
  • Insulin secretion-sensitivity index-2 (ISSI-2) > 800 on oral glucose tolerance test
  • BMI between 17 and 30
  • Signed informed consent

Who cannot join

  • Previous treatment (within 6 months) with synthetic exendin
  • Breast feeding
  • Current pregnancy
  • Renal dysfunction
  • Liver disease

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Radboudumc

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

In order to evaluate the difference in beta cell mass in women with and without a history of gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of the pancreas between these groups. Investigators propose to measure uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell mass. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data within this at-risk population for type 2 diabetes (T2D) will provide the investigators with more information on the role of beta cell mass in the predisposition for development of T2D leading to better knowledge on the pathophysiology of this disease. This could be of great interest for development of new treatment options.

Read the detailed description

Gestational diabetes Insulin is produced by pancreatic beta cells and is needed for optimal glucose homeostasis. In healthy individuals, the mass and function of beta cells changes to adapt to variations in insulin demand in the body. For example, adaptive beta cell hyperplasia, hypertrophy and hyperfunction occur in situations of increased metabolic demand, like pregnancy.

In rodents a 2-3 fold increase in beta cell mass is observed at the end of gestation. By the time of delivery, beta cell function as well as beta cell mass return to normal levels. Although to a lesser extent than in rodents, also in humans there have been studies indicating that the beta cell mass may increase during pregnancy and return to normal in the postpartum stage.

When there is no sufficient compensation during pregnancy due to failure in beta cell expansion or function, gestational diabetes mellitus (GDM) occurs.

GDM complicates 2-5% of pregnancies in Caucasian women and is characterized by glucose intolerance with the onset or first diagnosis during pregnancy. GDM can have serious consequences for both the child as well as the mother. Risks to the child include fetal macrosomia as well as long-term health consequences like obesity, hypertension, dyslipidemia, glucose intolerance and type 2 diabetes (T2D). Maternal risks include an increased probability of caesarean delivery accompanied by an increased risk of maternal morbidity.

In women with GDM, glucose homeostasis is returned to normal levels shortly after delivery. However, women with a single gestational diabetes pregnancy present with faster deterioration in insulin sensitivity and beta cell compensation compared to women without a history of gestational diabetes. These women therefore have a 7-fold increased risk of developing T2D in the future. Furthermore, women with a history of GDM have a 10-fold increased risk of developing GDM in future pregnancies.

GDM and T2D The prevalence of T2D in the Netherlands is 600.000-800.000 and each year ~70.000 new patients are diagnosed. Patients with T2D have a 2-4 times increased risk of developing cardiovascular disease. These complications seriously decrease the quality of life and life expectancy of T2D patients. The burden of this disease not only affects these patients but our society as well. Health care costs with respect to diabetes amounted to 814 million euro in 2005 in the Netherlands and indirect costs because of absence of work are unknown but thought to be substantial.

T2D is mainly characterized by defective insulin secretion and peripheral insulin resistance. It develops chronically over years to decades before it becomes apparent. Early in the disease progression, pancreatic beta cells respond to initial insulin resistance by increasing insulin secretion to preserve a near-normal glucose level. Over time the beta cell mass reduces gradually, leading to a decline in insulin secretion causing hyperglycemia. Beta cell failure is dependent on several factors like genetic predisposition, poor dietary control, glucotoxicity and lipotoxicity, liver steatosis and therapy itself.

In the process of development of disease many secondary changes in metabolism, hormonal signaling and body composition occur which are difficult to discriminate from those that initially started the pathophysiological process. Therefore, the early pathogenesis of T2D is still not completely understood. Risk factors for the development of T2D overlap with the risk factors for GDM. These common risk factors suggest an overlapping cause of the disease.

In patients with GDM glucose homeostasis cannot be maintained under conditions of increased metabolic demand. This fact, together with the increased risk of developing T2D in the future suggests a specific predisposition for beta cell dysfunction in these patients.

Beta cell mass in T2D Besides the well-known role of peripheral insulin resistance in the early pathogenesis of T2D, there is also evidence suggesting the importance of beta cell mass. Studies performed on autopsy material of T2D patients in various populations show a significantly reduced beta cell mass. This reduction could be explained by accelerated beta cell death in these patients. A genetic difference in beta cell mass could however also play a role. Large variations in fractional beta cell area have been shown between individuals in the pre- and postnatal growth period. Furthermore, a recent study by Brom et al. suggests that there is a large variation in beta cell mass between individuals. In this study beta cell mass was measured non-invasively in healthy subjects as well as type 1 diabetic patients by 111In-exendin-4 SPECT/CT. While the beta cell mass in these diabetic patients was found to be significantly lower than in healthy subjects, a wide range in beta cell mass was found in both groups. These results are in line with an earlier study where wide ranges in beta cell mass were found in pancreas obtained at autopsy of diabetic and non-diabetic subjects.

An initial deficit in beta cell mass could thus play a key role in the development of T2D. Patients with a history of GDM have a significantly increased risk of developing T2D. While an increase in beta cell mass has been found in healthy women during pregnancy, it is not yet known whether patients with GDM have a deficit in beta cell mass. While little is known about beta cell mass in women with a history of GDM, it is well recognized that these women have a chronic defect in beta cell function that progressively worsens in the years after the pregnancy and mediates their high risk of progression to T2D. This deterioration of beta cell function begins as early as the first year after delivery, is partly driven by hepatic insulin resistance, takes place in the presence of initial normal glucose tolerance, and precedes the development of abnormal glucose tolerance. Accordingly, women with a recent history of GDM represent a patient population in which there is beta cell dysfunction without the potential confounding effect of hyperglycemia (and resultant glucotoxicity).

Evaluation of beta cell mass in women with a history of GDM could thus be very beneficial for our understanding of the role of beta cell mass in the development of T2D. It would be of great interest to examine whether the population of women with a history of gestational diabetes, who have a significantly increased risk of developing T2D, have a lower mean beta cell mass compared to the population of women without a history of gestational diabetes.

Also for the development of new treatment options for T2D, more knowledge on the role of beta cell loss in the development of T2D would be beneficial. While current and new anti-diabetic drugs are mainly targeting insulin secretion and action or glucose uptake, evidence from animal experiments suggests the feasibility of regulating beta cell mass.

Imaging of beta cells in vivo Reliable, sensitive and specific visualization of living pancreatic beta cells in vivo is important to broaden the understanding of the role of beta cell mass in the onset and development of T2D. This could benefit further research in the causes of beta cell failure in T2D and therapeutic options to delay progressive loss of beta cells. Because of the multifactorial nature of T2D disease, defining a study population for assessment of beta cell mass is difficult. Patients with a history of GDM would be a very attractive population to study in this context as an at-risk cohort for T2D. These patients have a clear predisposition for development of T2D evidenced by their increased risk for developing this disease and the faster deterioration of insulin sensitivity and beta cell compensation.

GLP-1 receptor imaging by PET For specific non-invasive imaging of beta cells, investigators have developed a highly beta cell-specific radiolabeled exendin-based GLP-1 (glucagon-like peptide-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 in rats.

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
beta cell mass, exendin, GLP-1 PET
Medical subject headings
Diabetes, Gestational

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 groups in NCT03182296
Study groupRoleWhat they receive
Gestational diabetesExperimentalWomen with a history of gestational diabetes
Receives: Radiation: 68Ga-NODAGA-exendin-4 PET/CT
ControlActive comparatorWomen without a history of gestational diabetes
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.

  1. Pancreatic uptake of 68Ga-NODAGA-exendin-4

    Pancreatic tracer uptake by quantitative analysis of PET images

    Measured: 1 year

Secondary outcomes (1)
  1. C-peptide, HbA1c

    Correlation of tracer uptake and beta cell function

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2017
  2. Study start10 Nov 2016
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Comparison of women with and without a history of gestational diabetes
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03182296
Sponsor's protocol ID
NL56938.091.16
Status last verified
Jan 2024
First submitted
29 May 2017
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-NODAGA-exendin-4 PET/CT in people with Gestational Diabetes, run by Radboud University Medical Center at 1 site 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 12 inclusion and 5 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 5 Jan 2024. 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 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.

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?

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?

Pancreatic uptake of 68Ga-NODAGA-exendin-4 (time frame: 1 year). 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 5 Jan 2024.

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