Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Generally healthy Generally healthy |
|
| Type 2 diabetes mellitus Type 2 diabetes mellitus |
Outcome Measures
Primary Outcome Measures
- anthropometric measures and metabolic biomarkers indicative of prediabetes [Day one]
One blood sample taken on day 1 of the study
Secondary Outcome Measures
- intra-subject and inter-subject variability of analyzed biomarkers [within one month]
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.
Other Outcome Measures
- the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk [up to 3 years]
assessment of study data at the end of the study
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Obese and overweight subjects
-
Considered generally healthy
Exclusion Criteria:
- Clinically significant acute illness within 2 weeks before study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Profil Institut für Stoffwechselforschung GmbH | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Profil Institut für Stoffwechselforschung GmbH
Investigators
- Principal Investigator: Leona Plum-Mörschel, MD, Profil Institut für Stoffwechselforschung GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBDM-01