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Explorative Assessment of Biomarkers in Overweight and Obese Subjects

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ClinicalTrials.gov Identifier: NCT01910051
Recruitment Status : Recruiting
First Posted : July 29, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Prediabetes

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
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Generally healthy
Generally healthy
Type 2 diabetes mellitus
Type 2 diabetes mellitus


Outcome Measures

Primary Outcome Measures :
  1. anthropometric measures and metabolic biomarkers indicative of prediabetes [ Time Frame: Day one ]
    One blood sample taken on day 1 of the study


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Generally healthy or Type 2 Diabetes mellitus
Criteria

Inclusion Criteria:

  • Obese and overweight subjects
  • Considered generally healthy

Exclusion Criteria:

  • Clinically significant acute illness within 2 weeks before study procedures
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910051


Contacts
Contact: Elke Gurschke +4921314018 ext 411 regulatory@profil.com

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH Recruiting
Neuss, Germany, 41460
Contact: Elke Gurschke    +4921314018 ext 411    regulatory@profil.com   
Principal Investigator: Leona Plum-Mörschel, MD         
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Investigators
Principal Investigator: Leona Plum-Mörschel, MD Profil Institut für Stoffwechselforschung GmbH
More Information

Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01910051     History of Changes
Other Study ID Numbers: OBDM-01
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Overweight
Prediabetic State
Glucose Intolerance
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia