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Completed

NCT Number: NCT01406665

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gelre Ziekenhuis, Apeldoorn, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-age >20 years

  • additionally a priori intermediate risk for IGT/diabetes: by having at least one criterion from the metabolic syndrome, or by at least once having had an increased glucose or glycated hemoglobin value in the preceding two years, but these outside the range of diabetes/IGT

Exclusion criteria

-known diabetes mellitus

  • use of oral antidiabetics for other purposes than diabetes such as hepatic steatosis
  • local skin disease of the lower arm obviating skin autofluorescence measurement
  • known serious renal insufficiency (s-creatinine > 180 umol/l).
  • inability to fill in questionnaires

Treatment and study plan

Primary outcomes

  1. oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes

    Time frame: individually immediately following test, for study <26 weeks

    numbers of true and false positives and negatives for oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes are scored for Skin autofluorescence (based decision tree), FPG and HbA1c

Secondary outcomes

  1. Findrisk diabetes questionnaire score

    Time frame: individually immediately after test, for study <26 weeks

    Findrisk diabetes questionnaire score is based on anthropometric data and questionnaire.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Assessment of Value of Skin Autofluorescence in Detecting Diabetes Mellitus or Impaired Glucose Tolerance. Comparison With Fasting Plasma Glucose and Glycated Hb

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2011
Registry last updated
Aug 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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