Assessing Progression to Type-2 Diabetes (APT-2D): A Prospective Cohort Study Expanded From BRITE-SPOT (Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of Type 2 Diabetes)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes
- Pre Diabetes
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 30 years and 65 years
- Gender
- Both males and females
Description
This is a prospective open cohort study. The study will comprise the following periods: Screening • Complete screening checklist and informed consent form Procedures. Following the screening visit, subjects are required to return to undergo the following: Oral Glucose Tolerance Test (OGTT) to assess...
This is a prospective open cohort study. The study will comprise the following periods: Screening • Complete screening checklist and informed consent form Procedures. Following the screening visit, subjects are required to return to undergo the following: Oral Glucose Tolerance Test (OGTT) to assess glucose tolerance and beta cell function Frequently-Sampled Intravenous Glucose Tolerance test (FSIVGTT) to assess acute insulin response to glucose Euglycemic Hyperinsulinemic Clamp (EHC) to obtain the insulin sensitivity index and assess insulin action The Disposition index (DI) that quantifies the relationship between insulin sensitivity and insulin secretion, will be determined through the results obtained during FSIVGTT and EHC to determine subject's risk for Type 2 diabetes. OGTT will be repeated every 6 months to assess for conversion to Type 2 Diabetes. Plasma C-peptide, and glucose will be measured at 7 time points during the OGTT for minimal model assessment of beta cell function FSIVGTT and EHC will be repeated within 3 months of conversion to Type 2 Diabetes, or at 3 years from recruitment, whichever comes sooner. Normoglycemic Subjects: 800 Pre-Diabetic Subjects: 1500
Tracking Information
- NCT #
- NCT02838693
- Collaborators
- Janssen Pharmaceuticals
- National Medical Research Council (NMRC), Singapore
- Investigators
- Principal Investigator: Sue-Anne Toh, MBBChir, MSc, MA mdcsates@nus.edu.sg