Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH Identifier:
First received: July 11, 2013
Last updated: November 11, 2014
Last verified: November 2014

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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects

Resource links provided by NLM:

Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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

Biospecimen Retention:   Samples Without DNA

Blood samples

Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Generally healthy
Generally healthy
Type 2 diabetes mellitus
Type 2 diabetes mellitus

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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Generally healthy or Type 2 Diabetes mellitus


Inclusion Criteria:

  • Obese and overweight subjects
  • Considered generally healthy

Exclusion Criteria:

  • Clinically significant acute illness within 2 weeks before study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01910051

Contact: Elke Gurschke +4921314018 ext 411

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

No publications provided

Responsible Party: Profil Institut für Stoffwechselforschung GmbH Identifier: NCT01910051     History of Changes
Other Study ID Numbers: OBDM-01
Study First Received: July 11, 2013
Last Updated: November 11, 2014
Health Authority: Germany: not applicable processed this record on March 03, 2015