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

NCT05298735 | Completed DMC

• 1 other identifier: AC20142
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging

  30 minutes after contrast administration

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 28, 2022
• Study Start: March 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-02

Locations

GB (1)