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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406665
• Other study ID #: SAF-tree-IGTDM11
• Secondary ID: METc 2009-367
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: July 29, 2011
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: CCMO
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Impaired Glucose Tolerance

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuis	Apeldoorn	Gelderland
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes	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	individually immediately following test, for study <26 weeks	No
Secondary	Findrisk diabetes questionnaire score	Findrisk diabetes questionnaire score is based on anthropometric data and questionnaire.	individually immediately after test, for study <26 weeks	No