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

Sponsor

Ciusss de L'Est de l'Île de Montréal (Other)

Overall Status

Recruiting

CT.gov ID

NCT05385211

Collaborator

Juvenile Diabetes Research Foundation (Other), Institut de Recherches Cliniques de Montreal (Other)

100

Enrollment

Location

9.4

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Exocrine Pancreatic Insufficiency	Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine 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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Feb 6, 2023

Anticipated Study Completion Date :

Feb 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
People living with type 1 diabetes Participants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels.	Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency Blood samplings; Glucose monitoring; CFTR variants

Arm

Intervention/Treatment

People living with type 1 diabetes

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

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

Blood samplings; Glucose monitoring; CFTR variants

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de recherches cliniques de Montréal	Montréal	Quebec	Canada	H2

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sylvie Lesage, Ph.D, Ciusss de L'Est de l'Île de Montréal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sylvie Lesage, Principal investigator, Ciusss de L'Est de l'Île de Montréal

ClinicalTrials.gov Identifier:

NCT05385211

Other Study ID Numbers:

1-INO-2022-1126-A-N

First Posted:

May 23, 2022

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sylvie Lesage, Principal investigator, Ciusss de L'Est de l'Île de Montréal

Cystic fibrosis transmembrane regulator

Type 1 diabetes

Hypoglycemia

Exocrine pancreas

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of May 23, 2022