Type 1 DiabetesNCT05385211
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) and Exocrine Pancreatic Dysfunction in Type 1 Diabetes
An observational study of Type 1 Diabetes and Exocrine Pancreatic Insufficiency, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Exocrine Pancreatic Insufficiency
- What is being tested?
- Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2022to 30 Aug 2023
- 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: People living with type 1 diabetes
Who may be able to join
- Type 1 diabetes
- Living in Montreal
Who cannot join
- Pregnancy,
- Use of corticosteroid
- Use of medication known to have a relevant impact on glycemic control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes
This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. Up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as HbA1c levels). The main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in PWT1D, and to address the role of CFTR variants as potential contributors to pancreatic insufficiency.
Read the detailed description
In this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes.
Patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (EPI). EPI will be defined based on the levels of pancreatic enzymes (Amylase; lipase; and trypsinogen). As the prevalence of EPI in people living with type 1 diabetes (PWT1D) is ~50%, we expect roughly the same number of individuals into both groups (with or without EPI).
Variables :
Subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected.
Glucose variation will be assessed with a continuous glucose monitoring system for 1 month. Briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc..
From collected peripheral blood mononuclear cells (PBMCs) we will quantify CFTR function and level of expression, as well as identify CFTR variants by next generation sequencing.
- Conditions
- Type 1 Diabetes, Exocrine Pancreatic Insufficiency
- Being tested
- Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency
- Keywords
- Cystic fibrosis transmembrane regulator, Type 1 diabetes, Hypoglycemia, Exocrine pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1, Exocrine Pancreatic Insufficiency, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiencyOther
Blood samplings; Glucose monitoring; CFTR variants
| Study group | Role | What they receive |
|---|---|---|
| People living with type 1 diabetes | Participants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels. Receives: Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of hypoglycemic events
Continuous glucose monitoring will be used to assess glucose regulation
Measured: 1 month
Exocrine pancreatic insufficiency
Blood levels of pancreatic enzymes will be measured
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start30 Apr 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Institut de Recherches Cliniques de Montreal
- Responsible party
- Principal investigator, Sylvie Lesage, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Sylvie Lesage, Ph.D, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385211
- Sponsor's protocol ID
- 1-INO-2022-1126-A-N
- Status last verified
- Sep 2023
- First submitted
- 17 May 2022
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05385211
- Acronym / sponsor ID
- 1-INO-2022-1126-A-N
- Conditions
- Type 1 Diabetes, Exocrine Pancreatic Insufficiency
- Keywords
- Cystic fibrosis transmembrane regulator, Type 1 diabetes, Hypoglycemia, Exocrine pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Institut de Recherches Cliniques de Montreal
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 May 2022 (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.
This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. Up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as HbA1c levels). The main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in PWT1D, and to address the role of CFTR variants as potential contributors to pancreatic insufficiency.
Detailed description
In this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes.
Patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (EPI). EPI will be defined based on the levels of pancreatic enzymes (Amylase; lipase; and trypsinogen). As the prevalence of EPI in people living with type 1 diabetes (PWT1D) is ~50%, we expect roughly the same number of individuals into both groups (with or without EPI).
Variables :
Subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected.
Glucose variation will be assessed with a continuous glucose monitoring system for 1 month. Briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc..
From collected peripheral blood mononuclear cells (PBMCs) we will quantify CFTR function and level of expression, as well as identify CFTR variants by next generation sequencing.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People living with type 1 diabetes | – | Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiencyParticipants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with type 1 diabetes
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Living in Montreal
Key exclusion criteria (3 listed)
- Pregnancy,
- Use of corticosteroid
- Use of medication known to have a relevant impact on glycemic control.
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 |
|---|---|---|
| Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiencyBlood samplings; Glucose monitoring; CFTR variants | Other | People living with type 1 diabetes |
Primary outcome
Frequency and severity of hypoglycemic events
Time frame: 1 month
Continuous glucose monitoring will be used to assess glucose regulation
Exocrine pancreatic insufficiency
Time frame: Baseline
Blood levels of pancreatic enzymes will be measured
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 5 Sep 2023.
- 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.
Sylvie Lesage, Ph.D principal investigator
Ciusss de L'Est de l'Île de Montréal
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 and Exocrine Pancreatic Insufficiency, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 2 inclusion and 3 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 5 Sep 2023. 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 Canada. 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?
Frequency and severity of hypoglycemic events (time frame: 1 month). The study lists 2 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 5 Sep 2023.