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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01406665
First received: July 28, 2011
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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
Diabetes Mellitus
Impaired Glucose Tolerance

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • oGTT (WHO criteria)-defined impaired glucose tolerance or diabetes [ Time Frame: individually immediately following test, for study <26 weeks ] [ Designated as safety issue: No ]
    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:
  • Findrisk diabetes questionnaire score [ Time Frame: individually immediately after test, for study <26 weeks ] [ Designated as safety issue: No ]
    Findrisk diabetes questionnaire score is based on anthropometric data and questionnaire.


Biospecimen Retention:   None Retained

none retained


Enrollment: 218
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
increased diabetes risk
the recruited group consists of persons with moderate to high risk for impaired glucose tolerance or diabetes

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406665

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

No publications provided

Responsible Party: Prof. R.O.B. Gans, Head of Department Internal medicine, University medical Center Groningen Dept medicine
ClinicalTrials.gov Identifier: NCT01406665     History of Changes
Other Study ID Numbers: SAF-tree-IGTDM11, METc 2009-367
Study First Received: July 28, 2011
Last Updated: July 29, 2011
Health Authority: The Netherlands: CCMO

Keywords provided by University Medical Centre Groningen:
diabetes
impaired glucose tolerance

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

ClinicalTrials.gov processed this record on October 29, 2014