Explorative Assessment of Biomarkers in Overweight and Obese Subjects

Prediabetes Clinical Trial

Official title:

Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910051
• Other study ID #: OBDM-01
• Status: Completed
• Start date: September 25, 2013
• Est. completion date: December 23, 2021

Study information

• Verified date: December 2021
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Obese and overweight subjects

• Considered generally healthy

Exclusion Criteria:

• Clinically significant acute illness within 2 weeks before study procedures

Related Conditions & MeSH terms

• Glucose Intolerance
• Overweight
• Prediabetes
• Prediabetic State

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk	assessment of study data at the end of the study	up to 3 years
Primary	anthropometric measures and metabolic biomarkers indicative of prediabetes	One blood sample taken on day 1 of the study	Day one
Secondary	intra-subject and inter-subject variability of analyzed biomarkers	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.	within one month