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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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