Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus (Pancreas MEMRI)

Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom
      • University of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with type 1 diabetes mellitus (with or without detectable C-peptide levels)

Description

Inclusion Criteria:

• Age >18 years
• No regular medications
• No known significant medical conditions

Exclusion Criteria:

• Inability to consent
• Renal failure (eGFR <30 mL/min/1.73 m2)
• Standard MRI contraindications
• Pregnancy or breast feeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy volunteers; Healthy volunteers with no known significant medical conditions
Patients with type 1 diabetes; Patients with a diagnosis of type 1 diabetes (with or without detectable C-peptide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging	30 minutes after contrast administration

Collaborators and Investigators

• Sponsor: University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: AC20142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No