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

NCT05385211 | Completed

• 1 other identifier: 1-INO-2022-1126-A-N
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Exocrine Pancreatic Insufficiency

Keywords

Cystic fibrosis transmembrane regulator; Type 1 diabetes; Hypoglycemia; Exocrine pancreas

Outcome Measures

Primary Outcomes (2)

• Frequency and severity of hypoglycemic events

  Continuous glucose monitoring will be used to assess glucose regulation

  1 month

• Exocrine pancreatic insufficiency

  Blood levels of pancreatic enzymes will be measured

  Baseline

Study Arms (1)

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

Interventions

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

Blood samplings; Glucose monitoring; CFTR variants

People living with type 1 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with type 1 diabetes

You may qualify if:

• Type 1 diabetes
• Living in Montreal

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling Data from continuous glucose monitoring DNA for CFTR sequencing

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Exocrine Pancreatic Insufficiency; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Sylvie Lesage, Ph.D

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: April 30, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)