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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406665
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
Information provided by:
University Medical Center Groningen

Brief 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.

Condition or disease
Diabetes Mellitus Impaired Glucose Tolerance

Study Type : Observational
Actual Enrollment : 218 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Value of Skin Autofluorescence in Detecting Diabetes Mellitus or Impaired Glucose Tolerance. Comparison With Fasting Plasma Glucose and Glycated Hb
Study Start Date : October 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

increased diabetes risk
the recruited group consists of persons with moderate to high risk for impaired glucose tolerance or diabetes

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   None Retained
none retained

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects identified from an outpatient (vascular, lipid) hospital-based group, with an intermediate risk of (pre)diabetes, as defined by an age >35 years, and additionally at least one criterion from the metabolic syndrome, or at least once an increased glucose or HbA1c value in the preceding two years, but these outside the range of diabetes/IGT

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406665

Gelre Ziekenhuis
Apeldoorn, Gelderland, Netherlands, 7334 DZ
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen

Responsible Party: Prof. R.O.B. Gans, Head of Department Internal medicine, University medical Center Groningen Dept medicine Identifier: NCT01406665     History of Changes
Other Study ID Numbers: SAF-tree-IGTDM11
METc 2009-367 ( Other Identifier: Institutional Review Board (IRB) UMCG )
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by University Medical Center Groningen:
impaired glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases