The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.
The pre-screening assessments are designed to characterize the metabolic risk profile / prediabetic status in an unselected population of overweight and obese volunteers, aiming to pre-select high risk and prediabetic subjects as a target population who may specifically profit from primary diabetes intervention (prevention) strategies.
Study Type
OBSERVATIONAL
Enrollment
106
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
anthropometric measures and metabolic biomarkers indicative of prediabetes
One blood sample taken on day 1 of the study
Time frame: Day one
intra-subject and inter-subject variability of analyzed biomarkers
Several circulating markers including the traditionally used fasting serum insulin and fasting plasma glucose as well as an oral glucose tolerance test may serve as indicators of prediabetes. Importantly, these parameters show considerable intra-individual short-term variability. The assessments will therefore be repeated three times within a one month period to determine intra-subject variability of the analyzed parameters under the conditions that apply to the trial site and experimental conditions.
Time frame: within one month
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