NCT01910051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

8.2 years

First QC Date

July 11, 2013

Last Update Submit

December 28, 2021

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

  • anthropometric measures and metabolic biomarkers indicative of prediabetes

    One blood sample taken on day 1 of the study

    Day one

Secondary Outcomes (1)

  • intra-subject and inter-subject variability of analyzed biomarkers

    within one month

Other Outcomes (1)

  • the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk

    up to 3 years

Study Arms (2)

Generally healthy

Generally healthy

Type 2 diabetes mellitus

Type 2 diabetes mellitus

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Generally healthy or Type 2 Diabetes mellitus

You may qualify if:

  • Obese and overweight subjects
  • Considered generally healthy

You may not qualify if:

  • Clinically significant acute illness within 2 weeks before study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leona Plum-Mörschel, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 29, 2013

Study Start

September 25, 2013

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

DE(1)