NCT06862778

Brief Summary

This project aims to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study, a measurement protocol will be established to investigate whether SERS (combined with multivariate data analysis or machine learning algorithms) allows the diagnosis of patients with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 1, 2025

Last Update Submit

April 27, 2026

Conditions

Diabetes

Keywords

DiabetesSensingSERSGold nanoparticlesDiagnositcsSurface-enhanced Raman Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • SERS measurements to differentiate between healthy and diabetic patients

    SERS assessment of healthy and diabetic patient samples to identify unique spectroscopical characteristics to discriminate between healthy and diabetic patients

    Through study competition, up to 1 year

Study Arms (2)

Healthy

EXPERIMENTAL

The Raman spectra of healthy patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Diagnostic Test: SERS

Diabetes

EXPERIMENTAL

The Raman spectra of diabetic patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Diagnostic Test: SERS

Interventions

SERSDIAGNOSTIC_TEST

Spectroscopic assessment of serum samples from healthy and diabetic patients to identify characteristics for diagnosis.

Also known as: Surface-enhanced Raman Spectroscopy
DiabetesHealthy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at Nishtar Medical University
  • Patient age from 18 to 70 years
  • Confirmed disease (for diabetic group)

You may not qualify if:

  • Patients with severe concurrent diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen university hospital

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

February 2, 2024

Primary Completion

August 31, 2024

Study Completion

July 31, 2025

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

DE(1)