Explorative Assessment of Biomarkers in Overweight and Obese Subjects

Completed

• Conditions: Prediabetes

• Registration Number: NCT01910051
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

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 Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-29
• Study Start: 2013-09-25
• Status Verified: 2021-12
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Obese and overweight subjects
• Considered generally healthy

Exclusion Criteria

• Clinically significant acute illness within 2 weeks before study procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anthropometric measures and metabolic biomarkers indicative of prediabetes	Day one	One blood sample taken on day 1 of the study

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany