Explorative Assessment of Biomarkers in Overweight and Obese Subjects
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects|
- anthropometric measures and metabolic biomarkers indicative of prediabetes [ Time Frame: Day one ] [ Designated as safety issue: No ]One blood sample taken on day 1 of the study
- intra-subject and inter-subject variability of analyzed biomarkers [ Time Frame: within one month ] [ Designated as safety issue: No ]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.
- the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]assessment of study data at the end of the study
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Type 2 diabetes mellitus
Type 2 diabetes mellitus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910051
|Contact: Elke Gurschke||+4921314018 ext email@example.com|
|Profil Institut für Stoffwechselforschung GmbH||Recruiting|
|Neuss, Germany, 41460|
|Contact: Elke Gurschke +4921314018 ext 411 firstname.lastname@example.org|
|Principal Investigator: Leona Plum-Mörschel, MD|
|Principal Investigator:||Leona Plum-Mörschel, MD||Profil Institut für Stoffwechselforschung GmbH|