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

NCT ID: NCT05298735

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

Healthy volunteers with no known significant medical conditions

No interventions assigned to this group

Patients with type 1 diabetes

Patients with a diagnosis of type 1 diabetes (with or without detectable C-peptide)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AC20142

Identifier Type: -

Identifier Source: org_study_id

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