We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Explorative Assessment of Biomarkers in Overweight and Obese Subjects

This study is currently recruiting participants.
Verified September 2017 by Profil Institut für Stoffwechselforschung GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT01910051
First Posted: July 29, 2013
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
  Purpose
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
Prediabetes

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 ]
    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 ]
    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 ]
    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 Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: July 11, 2013
First Posted: July 29, 2013
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