NCT04137705

Brief Summary

To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

October 22, 2019

Last Update Submit

November 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics.

    To determine the repeatability of multiparametric MRI in the assessment of body composition and multiple organ structures obtained within a single MR scanning session (liver, pancreas, aorta, heart, kidney, lungs and spleen)

    24 months

Secondary Outcomes (1)

  • Assessment of the reproducibility (precision under different measurement conditions: same participants scanned on separate MRI scanners at both 1.5T and 3T) of multiparametric MRI for the assessment of body composition and multiple organ metrics.

    24 months

Other Outcomes (1)

  • Assessment of the mean differences in body composition and multiple organ metrics between healthy participants and those with type 2 diabetes acquired with multiparametric MRI.

    24 months

Interventions

A standardised MRI protocol that provides a number of quantitative metrics on liver and other organs relevant to type 2 Diabetes - pancreas, kidneys, spleen, heart, lungs and aorta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult volunteers, including healthy volunteers and individuals with Type 2 Diabetes (T2D).

You may qualify if:

  • Any person over 18 years of age.
  • Participant is willing and able to give informed consent for participation in the investigation.
  • EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer

You may not qualify if:

  • The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
  • Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beaver House

Oxford, OX1 2EH, United Kingdom

Location

Oxford Centre for Magnetic Resonance

Oxford, OX3 9DU, United Kingdom

Location

Gemini One

Oxford, OX4 2LL, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rajarshi Banerjee

    Perspectum

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

November 4, 2019

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations