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Skin Autofluorescence (AF) Decision Tree in Detecting Impaired Glucose Tolerance (IGT) or Diabetes Mellitus (DM)

NCT01406665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 218

Last updated 2011-08-01

No results posted yet for this study

Summary

Early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient because the best accepted standard, an oral glucose tolerance test (oGTT), is not feasible in a setting of screening or broad case-finding and other current methods lack in sensitivity. A previously reported study, and analysis of retrospective skin autofluorescence (AF) data, suggests that noninvasive skin AF may offer an alternative for detection of (pre)diabetes. The objective is to test the validity of a decision tree based on skin autofluorescence, and some simple clinical characteristics, as a detection tool for diabetes and impaired glucose tolerance. Sensitivity and specificity, positive and negative predictive value of this skin AF based decision model will be compared to those of fasting plasma glucose (FPG), glycated haemoglobin (HbA1c), and to two short questionnaires (Finnish Findrisk, and Cambridge score).

Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed in at least 120 persons with the characteristics described in the following paragraph. A Findrisk and Cambridge questionnaire will also be collected.

Conditions

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406665 on ClinicalTrials.gov