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) (APT-2D)

July 21, 2016 updated by: Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 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

Study Type

Observational

Enrollment (Anticipated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Sue-Anne Toh, MBBChir, MSc, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normoglycemic: 800 Pre-diabetics: 1,500

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Known or ongoing psychiatric disorders within 3 years
  3. Regularly use known drugs of abuse within 3 years
  4. Women who are pregnant or lactating
  5. Have donated blood of more than 500 mL within 4 weeks of study enrollment.
  6. 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)
  7. Uncontrolled hypertension (blood pressure [BP] >160/100mmHg
  8. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
  9. 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
  10. Known allergy to insulin
  11. History of bleeding diathesis or coagulopathy

  12. Any of the following laboratory values at screening:

    • LDL > 190mg/dL (>4.9mmol/L)
    • TG > 500mg/dL (>5.6mmol/L)
    • Hba1C >= 6.5%
    • Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
    • ALT > 3.0 x upper limit of normal
    • Estimated creatinine clearance <60 mL/min
  13. Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
  14. Significant change in weight (+/- 5%) during the past month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
APT-2D (Normoglycemic)
800 Normoglycemic
Procedure: Not applicable. This is an observational study.
Not applicable. This is an observational study.
APT-2D (Pre-Diabetic)
1,500 Pre-Diabetic
Procedure: Not applicable. This is an observational study.
Not applicable. This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in beta-cell function in Asian populations with normal glucose tolerance and prediabetes over 3 years.
Time Frame: Data for each participant will be analysed upon completion all their OGTT visits
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.
Time Frame: Data for each participant will be analysed upon completion of both of the FSIVGTT and EHC visits
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
Biomarker panel will be conducted through testing of plasma and serum samples.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicine

Collaborators

Janssen Pharmaceuticals
National Medical Research Council (NMRC), Singapore

Investigators

  • Principal Investigator: Sue-Anne Toh, MBBChir, MSc, MA, mdcsates@nus.edu.sg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

July 17, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28431754DIA4019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Not applicable. This is an observational study.

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