NCT05935839

Brief Summary

In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 28, 2023

Last Update Submit

June 28, 2023

Conditions

Diabetes Mellitus, Type 1Macroangiopathy

Outcome Measures

Primary Outcomes (1)

  • Visualization of tissue changes in diabetic patients using MSOT.

    Comparison of the quantitative percentage of oxygenated/deoxygenated hemoglobin determined by MSOT in adults and children with diabetes mellitus and an adult healthy control group.

    12 months

Study Arms (3)

Adult Patients with diabetes mellitus type 1

EXPERIMENTAL

* Laboratory-confirmed diagnosis of diabetes mellitus type 1 * Age 18-99 years * Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value \> 8.5 mmol/mol)

Device: Multispectral optoacoustic tomographyDiagnostic Test: Ankle Brachial IndexDiagnostic Test: Neuropathy Disability Score

Pediatric Patients with diabetes mellitus type 1

EXPERIMENTAL

* Laboratory-confirmed diagnosis of diabetes mellitus type 1 * Age 6-17 years * Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value \> 8.5 mmol/mol)

Device: Multispectral optoacoustic tomographyDiagnostic Test: Ankle Brachial IndexDiagnostic Test: Neuropathy Disability Score

Healthy volunteers

EXPERIMENTAL

\- Age 18-99 years

Device: Multispectral optoacoustic tomographyDiagnostic Test: Ankle Brachial IndexDiagnostic Test: Neuropathy Disability Score

Interventions

Multispectral optoacoustic tomographyDEVICE

Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.

Adult Patients with diabetes mellitus type 1Healthy volunteersPediatric Patients with diabetes mellitus type 1
Ankle Brachial IndexDIAGNOSTIC_TEST

Dual measurement of ABI index before and after physical exercise.

Adult Patients with diabetes mellitus type 1Healthy volunteersPediatric Patients with diabetes mellitus type 1
Neuropathy Disability ScoreDIAGNOSTIC_TEST

Single measurement of the NSS

Adult Patients with diabetes mellitus type 1Healthy volunteersPediatric Patients with diabetes mellitus type 1

Eligibility Criteria

Age6 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diabetes mellitus type 1
  • Laboratory-confirmed diagnosis of diabetes mellitus type 1
  • Age 18-99 years
  • Disease duration of at least 5, preferably 10 years with inadequate medication control (HbA1c value \> 8.5 mmol/mol)
  • Written informed consent
  • patients with diabetes mellitus type 1
  • Laboratory-confirmed diagnosis of diabetes mellitus type 1
  • Age 6-17 years
  • Duration of disease at least 5, better 10 years with inadequate medication control (HbA1c value \> 8.5 mmol/mol)
  • Written informed consent
  • Healthy subjects
  • Age 18-99 years
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Nursing mothers
  • Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry).
  • Tattoo in the area of the examination
  • Subcutaneous fat over 3 cm
  • Lack of written consent
  • Inability to perform sufficient (brief) physical exertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Ankle Brachial Index

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ferdinand Knieling, PD Dr. med.

CONTACT

+49 9131 85 41337ferdinand.knieling@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 7, 2023

Record last verified: 2023-06