Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

NCT ID: NCT05385211

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-08-30

Brief 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). 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.

Conditions

Type 1 Diabetes; Exocrine Pancreatic Insufficiency

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

People living with type 1 diabetes

Participants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels.

Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency

Intervention Type: OTHER

Blood samplings; Glucose monitoring; CFTR variants

Interventions

Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency

Blood samplings; Glucose monitoring; CFTR variants

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 1 diabetes
• Living in Montreal

Exclusion Criteria

• Pregnancy,
• Use of corticosteroid
• Use of medication known to have a relevant impact on glycemic control.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: collaborator

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Sylvie Lesage

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvie Lesage, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ciusss de L'Est de l'Île de Montréal

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

1-INO-2022-1126-A-N

Identifier Type: -

Identifier Source: org_study_id