Type 1 Diabetes MellitusGLP1-regNCT03785275
Beta Cell Imaging in T1D Patients With a Different Glycemic Control
An observational study of Type 1 Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The primary aim of this study is to measure (residual) beta cell mass in type 1 diabetes (T1D) patients with stable near-normal and unstable glucose control using PET/CT imaging, to improve the understanding of the relation between beta cell mass and glycemic control in T1D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- gallium-68-exendin PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Dec 2017to 9 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 18 individuals with T1D for at least 1 year with a minimum age of 18 years. This population consists of two groups that include 9 subjects with stable near-normal glucose control and 9 individuals with unstable glucose control. The differentiation between T1D patients with stable near-normal and unstable glucose control will be based on their HbA1c value, the number of severe hypoglycemic events and the patient's hypoglycaemic awareness.
Who may be able to join
- Group 1 (stable glycemic control)
- Age ≥18 years
- T1D diagnosed ≥1 year at the start of the study
- HbA1c <7 (<53 mmol/mol)
- 17≤ BMI ≤30 kg/m2
- No severe hypoglycemic events in the past year and a maximum of 2 severe hypoglycemic events in their entire life.
Show all 14Show fewer
- Intact hypoglycemic awareness
- Ability to sign informed consent
- Group 2 (unstable glycemic control) Age ≥18 years
- T1D diagnosed ≥1 year at the start of the study
- HbA1c >8.5 (>69 mmol/mol)
- 17≤ BMI ≤30 kg/m2
- Minimum of 2 severe hypoglycemic events in the past year, or an impaired awareness of hypoglycemia (subjects may comply with both criteria, but this is not a requirement)
- Ability to sign informed consent
Who cannot join
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- BMI <17 kg/m2 or BMI >30 kg/m2
- Age <18 years
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta Cell Imaging in Type 1 Diabetes With Stable Near-normal and Unstable Glucose Control Using PET
The primary aim of this study is to measure (residual) beta cell mass in type 1 diabetes (T1D) patients with stable near-normal and unstable glucose control using PET/CT imaging, to improve the understanding of the relation between beta cell mass and glycemic control in T1D.
Read the detailed description
Type 1 diabetes (T1D) is characterized by a progressive decrease in beta cell function due to an autoimmune attack on the beta cells, which will lead to a reduction in insulin secretion. Endogenous insulin secretion can be determined measuring C-peptide, which is secreted in equal amounts to insulin. The loss of insulin secretion, indicated by an immeasurable C-peptide level, will hamper glycemic control which results in increased glycated haemoglobin (HbA1c) levels. Also, hypoglycemic events can occur more frequently. Initially, the belief was that this could be explained by the loss of all pancreatic beta cells due to the autoimmune attack. However, recent literature suggests that a considerable number of beta cells can survive this attack. This could mean that certain beta cells survived, but have lost their function. The ratio of functional and non-functional residual beta cells might play an important role in the degree of glycemic control. It would therefore be of great interest to study residual beta cell mass in two types of T1D patients that differ in glycemic control. Although both types of patients receive treatment, one group of patients is characterized by a stable near-normal glucose control while the second group is characterized by an unstable glucose control. In case glycemic control mostly depends on beta cell function and less on beta cell mass, novel therapies could focus on the functional reactivation of these non-functional beta cells to restore overall beta cell function. This could especially be in favour of patients with an unstable glucose control. Beta cell mass will be determined using Ga-68-NODAGA-exendin-4 positron emission tomography (PET), which allows visualization of pancreatic beta cells as well as absolute quantification of tracer uptake, providing a measure for the pancreatic beta cell mass. The outcome of this study will lead to a better understanding of the relation between the amount of residual beta cells, beta cell function and the influence of glycemic control. This could provide new insights regarding the development of new therapies to improve beta cell function and glycemic control, which could lower disease burden and improve the patient's quality of life.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- gallium-68-exendin PET/CT
- Keywords
- Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallium-68-exendin PET/CTRadiation
PET/CT scan after injection with gallium-68-exendin
| Study group | Role | What they receive |
|---|---|---|
| Subjects with stable near-normal T1D | * Mixed-meal tolerance test
* Intravenous injection with gallium-68-exendin followed by a PET/CT scan Receives: Radiation: gallium-68-exendin PET/CT | |
| Subjects with unstable T1D | * Mixed-meal tolerance test
* Intravenous injection with gallium-68-exendin followed by a PET/CT scan Receives: Radiation: gallium-68-exendin PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta cell mass
Pancreatic uptake of the tracer is measured by quantitative analysis (measure for beta cell mass)
Measured: 2 years
Secondary outcomes (1)
Beta cell mass vs. beta cell function
The correlation of the measured beta cell mass to the beta cell function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start6 Dec 2017
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Why it stopped: It was not possible to include 9 study participants with unstable glucose in due time, and therefore 7 individuals with unstable glucose control were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785275
- Sponsor's protocol ID
- NL59582.091.17
- Acronym
- GLP1-reg
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Cell Imaging in Type 1 Diabetes With Stable Near-normal and Unstable Glucose Control Using PET
- ClinicalTrials.gov ID
- NCT03785275
- Acronym / sponsor ID
- GLP1-reg / NL59582.091.17
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Glycemic control
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It was not possible to include 9 study participants with unstable glucose in due time, and therefore 7 individuals with unstable glucose control were included.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 24 Dec 2018 (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 primary aim of this study is to measure (residual) beta cell mass in type 1 diabetes (T1D) patients with stable near-normal and unstable glucose control using PET/CT imaging, to improve the understanding of the relation between beta cell mass and glycemic control in T1D.
Detailed description
Type 1 diabetes (T1D) is characterized by a progressive decrease in beta cell function due to an autoimmune attack on the beta cells, which will lead to a reduction in insulin secretion. Endogenous insulin secretion can be determined measuring C-peptide, which is secreted in equal amounts to insulin. The loss of insulin secretion, indicated by an immeasurable C-peptide level, will hamper glycemic control which results in increased glycated haemoglobin (HbA1c) levels. Also, hypoglycemic events can occur more frequently. Initially, the belief was that this could be explained by the loss of all pancreatic beta cells due to the autoimmune attack. However, recent literature suggests that a considerable number of beta cells can survive this attack. This could mean that certain beta cells survived, but have lost their function. The ratio of functional and non-functional residual beta cells might play an important role in the degree of glycemic control. It would therefore be of great interest to study residual beta cell mass in two types of T1D patients that differ in glycemic control. Although both types of patients receive treatment, one group of patients is characterized by a stable near-normal glucose control while the second group is characterized by an unstable glucose control. In case glycemic control mostly depends on beta cell function and less on beta cell mass, novel therapies could focus on the functional reactivation of these non-functional beta cells to restore overall beta cell function. This could especially be in favour of patients with an unstable glucose control. Beta cell mass will be determined using Ga-68-NODAGA-exendin-4 positron emission tomography (PET), which allows visualization of pancreatic beta cells as well as absolute quantification of tracer uptake, providing a measure for the pancreatic beta cell mass. The outcome of this study will lead to a better understanding of the relation between the amount of residual beta cells, beta cell function and the influence of glycemic control. This could provide new insights regarding the development of new therapies to improve beta cell function and glycemic control, which could lower disease burden and improve the patient's quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with stable near-normal T1D | – | Radiation: gallium-68-exendin PET/CT* Mixed-meal tolerance test * Intravenous injection with gallium-68-exendin followed by a PET/CT scan |
| Subjects with unstable T1D | – | Radiation: gallium-68-exendin PET/CT* Mixed-meal tolerance test * Intravenous injection with gallium-68-exendin followed by a PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 18 individuals with T1D for at least 1 year with a minimum age of 18 years. This population consists of two groups that include 9 subjects with stable near-normal glucose control and 9 individuals with unstable glucose control. The differentiation between T1D patients with stable near-normal and unstable glucose control will be based on their HbA1c value, the number of severe hypoglycemic events and the patient's hypoglycaemic awareness.
Key inclusion criteria (14 listed)
- Group 1 (stable glycemic control)
- Age ≥18 years
- T1D diagnosed ≥1 year at the start of the study
- HbA1c <7 (<53 mmol/mol)
- 17≤ BMI ≤30 kg/m2
Key exclusion criteria (8 listed)
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
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 |
|---|---|---|
| gallium-68-exendin PET/CTPET/CT scan after injection with gallium-68-exendin | Radiation | Subjects with stable near-normal T1D, Subjects with unstable T1D |
Primary outcome
Beta cell mass
Time frame: 2 years
Pancreatic uptake of the tracer is measured by quantitative analysis (measure for beta cell mass)
1 secondary outcome
Beta cell mass vs. beta cell function
Time frame: 2 years
Results and safety
The study was stopped early (reason given: It was not possible to include 9 study participants with unstable glucose in due time, and therefore 7 individuals with unstable glucose control were included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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?
An observational study of Type 1 Diabetes Mellitus, 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 14 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Feb 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 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?
The study was stopped early (reason given: It was not possible to include 9 study participants with unstable glucose in due time, and therefore 7 individuals with unstable glucose control were included.). 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?
Beta cell mass (time frame: 2 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 14 Feb 2022.