Pre-diabetesAPT-2DNCT02838693
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)
An observational study of Pre-diabetes and Diabetes, run by Medicine at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Diabetes
- What is being tested?
- Not applicable. This is an observational study.
- Type of treatment
- Surgery or procedure
- How many people
- 2,300 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2016to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normoglycemic: 800 Pre-diabetics: 1,500
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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%
- 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
- 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
- Significant change in weight (+/- 5%) during the past month
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Sue-Anne Toh, MBBChir, MSc, MA, +65 67722195, mdcsates@nus.edu.sg
Sue-Anne Toh, MBBChir, MSc, MA
About this study
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.
Read the 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
- Conditions
- Pre-diabetes, Diabetes
- Being tested
- Not applicable. This is an observational study.
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable. This is an observational study.Procedure or surgery
Not applicable. This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| APT-2D (Normoglycemic) | 800 Normoglycemic Receives: Procedure: Not applicable. This is an observational study. | |
| APT-2D (Pre-Diabetic) | 1,500 Pre-Diabetic Receives: Procedure: Not applicable. This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Biomarker panel will be conducted through testing of plasma and serum samples.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals, National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor-investigator, Medicine, National University Hospital, Singapore
- Investigators
- Sue-Anne Toh, MBBChir, MSc, MA, Principal investigator, mdcsates@nus.edu.sg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838693
- Sponsor's protocol ID
- 28431754DIA4019
- Acronym
- APT-2D
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Tai ES, Goh SY, Lee JJ, Wong MS, Heng D, Hughes K, Chew SK, Cutter J, Chew W, Gu K, Chia KS, Tan CE. Lowering the criterion for impaired fasting glucose: impact on disease prevalence and associated risk of diabetes and ischemic heart disease. Diabetes Care. 2004 Jul;27(7):1728-34. doi: 10.2337/diacare.27.7.1728.
PubMed 15220254Bergman RN, Phillips LS, Cobelli C. Physiologic evaluation of factors controlling glucose tolerance in man: measurement of insulin sensitivity and beta-cell glucose sensitivity from the response to intravenous glucose. J Clin Invest. 1981 Dec;68(6):1456-67. doi: 10.1172/jci110398.
PubMed 7033284Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.
PubMed 8405710Chen M, Porte D Jr. The effect of rate and dose of glucose infusion on the acute insulin response in man. J Clin Endocrinol Metab. 1976 Jun;42(6):1168-75. doi: 10.1210/jcem-42-6-1168.
PubMed 932179Dalla Man C, Campioni M, Polonsky KS, Basu R, Rizza RA, Toffolo G, Cobelli C. Two-hour seven-sample oral glucose tolerance test and meal protocol: minimal model assessment of beta-cell responsivity and insulin sensitivity in nondiabetic individuals. Diabetes. 2005 Nov;54(11):3265-73. doi: 10.2337/diabetes.54.11.3265.
PubMed 16249454Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
PubMed 15111519Tan CE, Emmanuel SC, Tan BY, Jacob E. Prevalence of diabetes and ethnic differences in cardiovascular risk factors. The 1992 Singapore National Health Survey. Diabetes Care. 1999 Feb;22(2):241-7. doi: 10.2337/diacare.22.2.241.
PubMed 10333940Jin W, Patti ME. Genetic determinants and molecular pathways in the pathogenesis of Type 2 diabetes. Clin Sci (Lond). 2009 Jan;116(2):99-111. doi: 10.1042/CS20080090.
PubMed 19076063Levy J, Atkinson AB, Bell PM, McCance DR, Hadden DR. Beta-cell deterioration determines the onset and rate of progression of secondary dietary failure in type 2 diabetes mellitus: the 10-year follow-up of the Belfast Diet Study. Diabet Med. 1998 Apr;15(4):290-6. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-M.
PubMed 9585393Bagust A, Beale S. Deteriorating beta-cell function in type 2 diabetes: a long-term model. QJM. 2003 Apr;96(4):281-8. doi: 10.1093/qjmed/hcg040.
PubMed 12651972Turner R, Stratton I, Horton V, Manley S, Zimmet P, Mackay IR, Shattock M, Bottazzo GF, Holman R. UKPDS 25: autoantibodies to islet-cell cytoplasm and glutamic acid decarboxylase for prediction of insulin requirement in type 2 diabetes. UK Prospective Diabetes Study Group. Lancet. 1997 Nov 1;350(9087):1288-93. doi: 10.1016/s0140-6736(97)03062-6.
PubMed 9357409Matthews DR, Cull CA, Stratton IM, Holman RR, Turner RC. UKPDS 26: Sulphonylurea failure in non-insulin-dependent diabetic patients over six years. UK Prospective Diabetes Study (UKPDS) Group. Diabet Med. 1998 Apr;15(4):297-303. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-W.
PubMed 9585394Donnan PT, MacDonald TM, Morris AD. Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: a retrospective cohort study. Diabet Med. 2002 Apr;19(4):279-84. doi: 10.1046/j.1464-5491.2002.00689.x.
PubMed 11942998Ringborg A, Lindgren P, Yin DD, Martinell M, Stalhammar J. Time to insulin treatment and factors associated with insulin prescription in Swedish patients with type 2 diabetes. Diabetes Metab. 2010 Jun;36(3):198-203. doi: 10.1016/j.diabet.2009.11.006. Epub 2010 Mar 28.
PubMed 20347376Cook MN, Girman CJ, Stein PP, Alexander CM, Holman RR. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):995-1000. doi: 10.2337/diacare.28.5.995.
PubMed 15855556
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02838693
- Acronym / sponsor ID
- APT-2D / 28431754DIA4019
- Conditions
- Pre-diabetes, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- MedicineUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals, National Medical Research Council (NMRC), Singapore
- Study start
- Mar 2016
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APT-2D (Normoglycemic) | – | Procedure: Not applicable. This is an observational study.800 Normoglycemic |
| APT-2D (Pre-Diabetic) | – | Procedure: Not applicable. This is an observational study.1,500 Pre-Diabetic |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normoglycemic: 800 Pre-diabetics: 1,500
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable. This is an observational study.Not applicable. This is an observational study. | Procedure or surgery | APT-2D (Normoglycemic), APT-2D (Pre-Diabetic) |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Background: PubMed 15220254Tai ES, Goh SY, Lee JJ, Wong MS, Heng D, Hughes K, Chew SK, Cutter J, Chew W, Gu K, Chia KS, Tan CE. Lowering the criterion for impaired fasting glucose: impact on disease prevalence and associated risk of diabetes and ischemic heart disease. Diabetes Care. 2004 Jul;27(7):1728-34. doi: 10.2337/diacare.27.7.1728.
- Background: PubMed 7033284Bergman RN, Phillips LS, Cobelli C. Physiologic evaluation of factors controlling glucose tolerance in man: measurement of insulin sensitivity and beta-cell glucose sensitivity from the response to intravenous glucose. J Clin Invest. 1981 Dec;68(6):1456-67. doi: 10.1172/jci110398.
- Background: PubMed 8405710Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.
- Background: PubMed 932179Chen M, Porte D Jr. The effect of rate and dose of glucose infusion on the acute insulin response in man. J Clin Endocrinol Metab. 1976 Jun;42(6):1168-75. doi: 10.1210/jcem-42-6-1168.
- Background: PubMed 16249454Dalla Man C, Campioni M, Polonsky KS, Basu R, Rizza RA, Toffolo G, Cobelli C. Two-hour seven-sample oral glucose tolerance test and meal protocol: minimal model assessment of beta-cell responsivity and insulin sensitivity in nondiabetic individuals. Diabetes. 2005 Nov;54(11):3265-73. doi: 10.2337/diabetes.54.11.3265.
- Background: PubMed 15111519Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
- Background: PubMed 10333940Tan CE, Emmanuel SC, Tan BY, Jacob E. Prevalence of diabetes and ethnic differences in cardiovascular risk factors. The 1992 Singapore National Health Survey. Diabetes Care. 1999 Feb;22(2):241-7. doi: 10.2337/diacare.22.2.241.
- Background: PubMed 19076063Jin W, Patti ME. Genetic determinants and molecular pathways in the pathogenesis of Type 2 diabetes. Clin Sci (Lond). 2009 Jan;116(2):99-111. doi: 10.1042/CS20080090.
- Background: PubMed 9585393Levy J, Atkinson AB, Bell PM, McCance DR, Hadden DR. Beta-cell deterioration determines the onset and rate of progression of secondary dietary failure in type 2 diabetes mellitus: the 10-year follow-up of the Belfast Diet Study. Diabet Med. 1998 Apr;15(4):290-6. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-M.
- Background: PubMed 12651972Bagust A, Beale S. Deteriorating beta-cell function in type 2 diabetes: a long-term model. QJM. 2003 Apr;96(4):281-8. doi: 10.1093/qjmed/hcg040.
- Background: PubMed 9357409Turner R, Stratton I, Horton V, Manley S, Zimmet P, Mackay IR, Shattock M, Bottazzo GF, Holman R. UKPDS 25: autoantibodies to islet-cell cytoplasm and glutamic acid decarboxylase for prediction of insulin requirement in type 2 diabetes. UK Prospective Diabetes Study Group. Lancet. 1997 Nov 1;350(9087):1288-93. doi: 10.1016/s0140-6736(97)03062-6.
- Background: PubMed 9585394Matthews DR, Cull CA, Stratton IM, Holman RR, Turner RC. UKPDS 26: Sulphonylurea failure in non-insulin-dependent diabetic patients over six years. UK Prospective Diabetes Study (UKPDS) Group. Diabet Med. 1998 Apr;15(4):297-303. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-W.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue-Anne Toh, MBBChir, MSc, MA principal investigator
mdcsates@nus.edu.sg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-diabetes and Diabetes, run by Medicine at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sue-Anne Toh, MBBChir, MSc, MA (+65 67722195, mdcsates@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838693, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.