DIRECT
Diabetes research on patient stratification
groups: IMI Projects
tags: IMI Translational Medicine
- First Name
- Hartmut
- Last Name
- Ruetten
- Affiliation
- Sanofi
- hartmut.ruetten@sanofi.com
- Business Phone Number
- 496930513547
- Business Fax Number
- -
- Business Address
- Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Geb. H823, 65926 Frankfurt a.M.
- Project Website
- http://www.direct-diabetes.org
- Version
- ongoing
- Date of creation of the dataset
- 2012-05-01
- Date of the last update of the dataset
- 2016-09-01
- Funding
- IMI
- Reference Publications
- Diabetologia. 2014 Jun;57(6):1132-42; Diabetes Care. 2014;37(3):718-24;
- Data Standards Implemented
- -
- Therapeutic Area Standards (Disease Area)
- Diabetes
- Study Protocal Description
- Study outline is available in Diabetologia (2014) 57:1132–1142.
- Multi-center Study
- True
- Description of Cohorts
- Diabetologia (2014) 57:1132–1142
- Study Type
- OBSERVATIONAL
- Study Type Comment
- -
- Primary Purpose
- Identification of risk prediction marker(s) for progression from pre-diabetes to diabetes or diabetes progression
- Study Phase
- Interim analysis
- Intervention Model
- -
- Study Classification
- -
- Indication
- -
- Age Range (Low Limit) of Study
- 35
- Age Range (Upper Limit) of Study
- 75
- Age Unit (of the above ranges)
- Year
- BMI Range
- 20-50
- BMI Range (lower limit)
- -
- BMI Range (upper limit)
- -
- Informed Consent
- True
- Planned Arm (Description of Sub-cohorts)
- -
- Name of Treatment
- -
- Standardized Name of Treatment
- -
- Category
- -
- Dose Description
- -
- Organism
- Homo sapiens
- Body System or Organ Class
- -
- Total Number of (Human) Subjects
- 3050
- Total Number of (Non-Human) Subjects
- 3050
- Number of Subjects in Each Cohorts (if multi-cohorts)
- 2300 pre-diabetics; 850 type 2 Diabetes oatients
- Detail Subject Composition
- -
- Type of Samples Collected
- Serum Plasma Urine faeces
- Number of Samples Collected
- from all 3.050 subjects
- Samples Details
- -
- Secondary Analysis
- Whole genome sequencing;RNASeq;Clinical imaging;Metabolomics;Proteomics