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)

NCT02838693 | Unknown DMC

• 1 other identifier: 28431754DIA4019
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief Summary

The Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of Type 2 Diabetes (BRITE-SPOT) has been set up to prospectively collect clinical data and biologically relevant samples from individuals with, and at risk for type 2 diabetes (T2D), with the aim of delineating factors related to susceptibility, progression, complications and response to treatment. Expanded from BRITE-SPOT, Assessing the Progression to Type - 2 Diabetes (APT-2D) is a prospective cohort with a focus on non-diabetics (normoglycemic or prediabetic), to expand the sample size and depth of metabolic phenotyping in these upstream groups, with the more targeted aim of delineating factors related to insulin sensitivity versus secretion, that relate to progression to T2D.

Conditions

Pre-diabetes; Diabetes

Outcome Measures

Primary Outcomes (2)

• Changes in beta-cell function in Asian populations with normal glucose tolerance and prediabetes over 3 years.

  Glucose \& c-peptide laboratory results, from OGTT, will be used to assess glucose tolerance and beta cell function

  Data for each participant will be analysed upon completion all their OGTT visits

• Changes in insulin sensitivity in Asian populations with normal glucose tolerance and prediabetes over 3 years. Data will be presented at the end of 5.5years.

  Disposition index assessed via glucose and insulin results from FSIVGTT and EHC.

  Data for each participant will be analysed upon completion of both of the FSIVGTT and EHC visits

Secondary Outcomes (1)

• To discover and/or validate biomarkers that predict which subjects will progress from NGT to prediabetes and/or from prediabetes to diabetes. Data will be presented at the end of 5.5years.

  All samples collected during the study will be consolidated at the end of 5.5years or upon study completion, whichever that comes first, and analysed in one single batch to ensure consistency of the data

Study Arms (2)

APT-2D (Normoglycemic)

800 Normoglycemic

Procedure: Not applicable. This is an observational study.

APT-2D (Pre-Diabetic)

1,500 Pre-Diabetic

Procedure: Not applicable. This is an observational study.

Interventions

Not applicable. This is an observational study. PROCEDURE

Not applicable. This is an observational study.

APT-2D (Normoglycemic); APT-2D (Pre-Diabetic)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normoglycemic: 800 Pre-diabetics: 1,500

You may qualify if:

• Ability to give informed consent
• At least 30 years old, and not older than 65 years
• Overtly healthy males or females, as determined by medical history, physical examination and laboratory results
• Not on any regular medications. Subjects using traditional medicine concomitantly will also be excluded in this study

You may not qualify if:

• History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
• Known or ongoing psychiatric disorders within 3 years
• Regularly use known drugs of abuse within 3 years
• Women who are pregnant or lactating
• Have donated blood of more than 500 mL within 4 weeks of study enrollment.
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
• Uncontrolled hypertension (blood pressure \[BP\] \>160/100mmHg
• Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
• Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
• Known allergy to insulin
• History of bleeding diathesis or coagulopathy
• Any of the following laboratory values at screening:
• LDL \> 190mg/dL (\>4.9mmol/L)
• TG \> 500mg/dL (\>5.6mmol/L)
• Hba1C \>= 6.5%

Sponsors & Collaborators

• Medicine: lead
• Janssen Pharmaceuticals: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (20)

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  PMID: 41192939 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Storage of plasma and serum

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sue-Anne Toh, MBBChir, MSc, MA

  mdcsates@nus.edu.sg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue-Anne Toh, MBBChir, MSc, MA

CONTACT

+65 67722195; mdcsates@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Sue-Anne Toh Ee Shiow

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 20, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 22, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)