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

Type 1 Diabetes Clinical Trial

Official title:

CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385211
• Other study ID #: 1-INO-2022-1126-A-N
• Status: Completed
• Start date: April 30, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Exocrine Pancreatic Insufficiency
• Type 1 Diabetes

Intervention

Other:
• Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency
Blood samplings; Glucose monitoring; CFTR variants

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Institut de Recherches Cliniques de Montreal, Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of hypoglycemic events	Continuous glucose monitoring will be used to assess glucose regulation	1 month
Primary	Exocrine pancreatic insufficiency	Blood levels of pancreatic enzymes will be measured	Baseline