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Explorative Assessment of Biomarkers in Overweight and Obese Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Profil Institut für Stoffwechselforschung GmbH
Sponsor:
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01910051
First received: July 11, 2013
Last updated: November 11, 2014
Last verified: November 2014

July 11, 2013
November 11, 2014
September 2013
August 2016   (final data collection date for primary outcome measure)
anthropometric measures and metabolic biomarkers indicative of prediabetes [ Time Frame: Day one ] [ Designated as safety issue: No ]
One blood sample taken on day 1 of the study
Same as current
Complete list of historical versions of study NCT01910051 on ClinicalTrials.gov Archive Site
intra-subject and inter-subject variability of analyzed biomarkers [ Time Frame: within one month ] [ Designated as safety issue: No ]
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.
Same as current
the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
assessment of study data at the end of the study
Same as current
 
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples

Probability Sample

Generally healthy or Type 2 Diabetes mellitus

Prediabetes
Not Provided
  • Generally healthy
    Generally healthy
  • Type 2 diabetes mellitus
    Type 2 diabetes mellitus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese and overweight subjects
  • Considered generally healthy

Exclusion Criteria:

  • Clinically significant acute illness within 2 weeks before study procedures
Both
18 Years to 85 Years
Yes
Contact: Elke Gurschke +4921314018 ext 411 regulatory@profil.com
Germany
 
NCT01910051
OBDM-01
No
Profil Institut für Stoffwechselforschung GmbH
Profil Institut für Stoffwechselforschung GmbH
Not Provided
Principal Investigator: Leona Plum-Mörschel, MD Profil Institut für Stoffwechselforschung GmbH
Profil Institut für Stoffwechselforschung GmbH
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP