The aim of the current study proposal is to test the validity of a decision tree focused on skin autofluorescence, and based on the results described above, as a detection tool for diabetes and impaired glucose tolerance in 2 new cohorts, one in an…
ID
Source
Brief title
Condition
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
sensitivity, specificity, positive and negative predicitve value SAF for
diagnosis diabetes or IGT, according to ADA criteria when using GTT
Secondary outcome
comparison test criteria SAF with those of fasting or historical glucose and
HbA1c levels
Background summary
Detection of diabetes and impaired glucose tolerance (IGT) now depends on
suboptimal tools. Recently it has been shown that noninvasive SAF is superior
to plasma glucose and HbA1c in detection of diabetes as comfirmed by a glucose
tolernace test (GTT). Similar results have been found using SAF and a simple
decision tree in a group of high risk of diabetes persons for whom GTTs and SAF
were available. Preliminary cut-off values for SAF and the decision tree have
been made. The aimm of the current proposal is to test the SAF and used
cutt-off values of SAF and decision tress in an intermediate risk of diabetes
group.
Study objective
The aim of the current study proposal is to test the validity of a decision
tree focused on skin autofluorescence, and based on the results described
above, as a detection tool for diabetes and impaired glucose tolerance in 2 new
cohorts, one in an outpatient based intermediate risk group, the other in a
low-risk primary care group.
Study design
Comparative study of SAF, fasting and historical plasma glucose and HbA1c for
detecting GTT-detected diabetes and IGT in persons at intermdiate risk
recruited initially in the UMCG Internal Medicine ooutpatients. If good test
characteristics of SAF and decision tree are confirmed A separate second studiy
will be done in lower risk primary care persosn (taking this second step will
be reported to METc via an amendment)
Study burden and risks
GTT is usually done in the study subjects. The noninvasive and rapid, safe SAF
measurement is not burdensome to the participants.
Hanzeplein 1/postbus 30001
9700 RB groningen
NL
Hanzeplein 1/postbus 30001
9700 RB groningen
NL
Listed location countries
Age
Inclusion criteria
risk of diabetes
Exclusion criteria
recent cardiovascular event or serious infection, renal insufficiency, extreme obesity (BMI >35)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31094.042.09 |