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Completed

NCT Number: NCT01910051

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese and overweight subjects
  • Considered generally healthy

Exclusion criteria

  • Clinically significant acute illness within 2 weeks before study procedures

Treatment and study plan

Primary outcomes

  1. anthropometric measures and metabolic biomarkers indicative of prediabetes

    Time frame: Day one

    One blood sample taken on day 1 of the study

Secondary outcomes

  1. intra-subject and inter-subject variability of analyzed biomarkers

    Time frame: 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 outcomes

  1. the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk

    Time frame: up to 3 years

    assessment of study data at the end of the study

Sponsors and collaborators

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2013
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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