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

Completed

• Conditions: Type 1 Diabetes; Exocrine Pancreatic Insufficiency
• Interventions: Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency

• Registration Number: NCT05385211
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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.

Study Timeline

• Study Start: 2022-04-30
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-23
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People living with type 1 diabetes	Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency	Participants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels.

Primary Outcome Measures

Name	Time	Method
Frequency and severity of hypoglycemic events	1 month	Continuous glucose monitoring will be used to assess glucose regulation
Exocrine pancreatic insufficiency	Baseline	Blood levels of pancreatic enzymes will be measured

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montréal, Quebec, Canada