Explorative Assessment of Biomarkers in Overweight and Obese Subjects

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01910051

Enrollment

106

Registered

2013-07-29

Start date

2013-09-25

Completion date

2021-12-23

Last updated

2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Obese and overweight subjects * Considered generally healthy

Exclusion criteria

* Clinically significant acute illness within 2 weeks before study procedures

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results