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Explorative Assessment of Biomarkers in Overweight and Obese Subjects

NCT ID: NCT01910051

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-25

Study Completion Date

2021-12-23

Brief Summary

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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

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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.

Conditions

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Prediabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Generally healthy

Generally healthy

No interventions assigned to this group

Type 2 diabetes mellitus

Type 2 diabetes mellitus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Obese and overweight subjects
* Considered generally healthy

Exclusion Criteria

* Clinically significant acute illness within 2 weeks before study procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leona Plum-Mörschel, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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OBDM-01

Identifier Type: -

Identifier Source: org_study_id