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NCT05298735 Clinical Trial

Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

— Pancreas MEMRI  

Official title:
Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05298735
Other study ID # AC20142
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date January 31, 2022

Study information
Verified date February 2022
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University of Edinburgh Edinburgh Scotland

Sponsors (1)
Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging 30 minutes after contrast administration
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