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OpenTrials
Completed

NCT Number: NCT05298735

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, Scotland, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 30 minutes after contrast administration

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Acronym: Pancreas MEMRI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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