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Clinical Trials/NCT01910051
NCT01910051CompletedNot Applicable

Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects

Profil Institut für Stoffwechselforschung GmbH1 site in 1 country106 target enrollmentStarted: September 25, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
106
Locations
1
Primary Endpoint
anthropometric measures and metabolic biomarkers indicative of prediabetes
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Obese and overweight subjects
  • •Considered generally healthy

Exclusion Criteria

  • •Clinically significant acute illness within 2 weeks before study procedures

Outcomes

Primary Outcomes

anthropometric measures and metabolic biomarkers indicative of prediabetes

Time Frame: Day one

One blood sample taken on day 1 of the study

Secondary Outcomes

  • intra-subject and inter-subject variability of analyzed biomarkers(within one month)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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