Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-03 @ 11:30 AM
Study NCT ID:
NCT02838693
Status:
UNKNOWN
Last Update Posted:
2016-07-22
First Post:
2016-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Storage of plasma and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-07-17', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in beta-cell function in Asian populations with normal glucose tolerance and prediabetes over 3 years.', 'timeFrame': 'Data for each participant will be analysed upon completion all their OGTT visits', 'description': 'Glucose \\& c-peptide laboratory results, from OGTT, will be used to assess glucose tolerance and beta cell function'}, {'measure': '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.', 'timeFrame': 'Data for each participant will be analysed upon completion of both of the FSIVGTT and EHC visits', 'description': 'Disposition index assessed via glucose and insulin results from FSIVGTT and EHC.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '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', 'description': 'Biomarker panel will be conducted through testing of plasma and serum samples.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pre-diabetes', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '15220254', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7033284', 'type': 'BACKGROUND', 'citation': 'Bergman 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.'}, {'pmid': '8405710', 'type': 'BACKGROUND', 'citation': 'Kahn 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.'}, {'pmid': '932179', 'type': 'BACKGROUND', 'citation': 'Chen 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.'}, {'pmid': '16249454', 'type': 'BACKGROUND', 'citation': 'Dalla 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.'}, {'pmid': '15111519', 'type': 'BACKGROUND', 'citation': 'Wild 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.'}, {'pmid': '10333940', 'type': 'BACKGROUND', 'citation': 'Tan 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.'}, {'pmid': '19076063', 'type': 'BACKGROUND', 'citation': 'Jin 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.'}, {'pmid': '9585393', 'type': 'BACKGROUND', 'citation': 'Levy 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.'}, {'pmid': '12651972', 'type': 'BACKGROUND', 'citation': 'Bagust 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.'}, {'pmid': '9357409', 'type': 'BACKGROUND', 'citation': 'Turner 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.'}, {'pmid': '9585394', 'type': 'BACKGROUND', 'citation': 'Matthews 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.'}, {'pmid': '11942998', 'type': 'BACKGROUND', 'citation': 'Donnan 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.'}, {'pmid': '20347376', 'type': 'BACKGROUND', 'citation': 'Ringborg 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.'}, {'pmid': '15855556', 'type': 'BACKGROUND', 'citation': 'Cook 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.'}, {'pmid': '24186880', 'type': 'BACKGROUND', 'citation': 'Zhou K, Donnelly LA, Morris AD, Franks PW, Jennison C, Palmer CN, Pearson ER. Clinical and genetic determinants of progression of type 2 diabetes: a DIRECT study. Diabetes Care. 2014;37(3):718-724. doi: 10.2337/dc13-1995. Epub 2013 Nov 1.'}, {'pmid': '15286737', 'type': 'BACKGROUND', 'citation': 'Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004 Aug;3(8):711-5. doi: 10.1038/nrd1470. No abstract available.'}, {'pmid': '2153255', 'type': 'BACKGROUND', 'citation': 'Riese DJ 2nd, Settleman J, Neary K, DiMaio D. Bovine papillomavirus E2 repressor mutant displays a high-copy-number phenotype and enhanced transforming activity. J Virol. 1990 Feb;64(2):944-9. doi: 10.1128/JVI.64.2.944-949.1990.'}, {'pmid': '20168317', 'type': 'BACKGROUND', 'citation': "Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov. 2010 Mar;9(3):203-14. doi: 10.1038/nrd3078. Epub 2010 Feb 19."}, {'pmid': '41192939', 'type': 'DERIVED', 'citation': 'Tsai MH, Goh CE, Lee MH, Seah F, Lim M, Febriana E, Fu J, Yip JK, Preshaw P, Toh SES. Associations between perceived stress and glycemic measures: gender and age as moderators. BMJ Open Diabetes Res Care. 2025 Nov 4;13(6):e005368. doi: 10.1136/bmjdrc-2025-005368.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This is a prospective open cohort study.\n\nThe study will comprise the following periods:\n\nScreening\n\n• Complete screening checklist and informed consent form\n\nProcedures.\n\n* Following the screening visit, subjects are required to return to undergo the following:\n\n * Oral Glucose Tolerance Test (OGTT) to assess glucose tolerance and beta cell function\n * Frequently-Sampled Intravenous Glucose Tolerance test (FSIVGTT) to assess acute insulin response to glucose\n * Euglycemic Hyperinsulinemic Clamp (EHC) to obtain the insulin sensitivity index and assess insulin action\n* 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.\n* 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\n* FSIVGTT and EHC will be repeated within 3 months of conversion to Type 2 Diabetes, or at 3 years from recruitment, whichever comes sooner.\n\nNormoglycemic Subjects: 800 Pre-Diabetic Subjects: 1500"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normoglycemic: 800 Pre-diabetics: 1,500', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to give informed consent\n2. At least 30 years old, and not older than 65 years\n3. Overtly healthy males or females, as determined by medical history, physical examination and laboratory results\n4. Not on any regular medications. Subjects using traditional medicine concomitantly will also be excluded in this study\n\nExclusion Criteria:\n\n1. 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\n2. Known or ongoing psychiatric disorders within 3 years\n3. Regularly use known drugs of abuse within 3 years\n4. Women who are pregnant or lactating\n5. Have donated blood of more than 500 mL within 4 weeks of study enrollment.\n6. 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)\n7. Uncontrolled hypertension (blood pressure \\[BP\\] \\>160/100mmHg\n8. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1\n9. 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\n10. Known allergy to insulin\n11. History of bleeding diathesis or coagulopathy\n12. Any of the following laboratory values at screening:\n\n * LDL \\> 190mg/dL (\\>4.9mmol/L)\n * TG \\> 500mg/dL (\\>5.6mmol/L)\n * Hba1C \\>= 6.5%\n * Fasting glucose \\>=126mg/dL(\\>=7mmol/L) or 2 hour post-prandial glucose \\>=200mg/dL (\\>=11.1mmol/L)\n * ALT \\> 3.0 x upper limit of normal\n * Estimated creatinine clearance \\<60 mL/min\n13. 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\n14. Significant change in weight (+/- 5%) during the past month'}, 'identificationModule': {'nctId': 'NCT02838693', 'acronym': 'APT-2D', 'briefTitle': '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)', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '28431754DIA4019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'APT-2D (Normoglycemic)', 'description': '800 Normoglycemic', 'interventionNames': ['Procedure: Not applicable. This is an observational study.']}, {'label': 'APT-2D (Pre-Diabetic)', 'description': '1,500 Pre-Diabetic', 'interventionNames': ['Procedure: Not applicable. This is an observational study.']}], 'interventions': [{'name': 'Not applicable. This is an observational study.', 'type': 'PROCEDURE', 'description': 'Not applicable. This is an observational study.', 'armGroupLabels': ['APT-2D (Normoglycemic)', 'APT-2D (Pre-Diabetic)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Sue-Anne Toh, MBBChir, MSc, MA', 'role': 'CONTACT', 'email': 'mdcsates@nus.edu.sg', 'phone': '+65 67722195'}, {'name': 'Sue-Anne Toh, MBBChir, MSc, MA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Sue-Anne Toh, MBBChir, MSc, MA', 'role': 'CONTACT', 'email': 'mdcsates@nus.edu.sg', 'phone': '+65 67722195'}], 'overallOfficials': [{'name': 'Sue-Anne Toh, MBBChir, MSc, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mdcsates@nus.edu.sg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'National Medical Research Council (NMRC), Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Sue-Anne Toh Ee Shiow', 'investigatorFullName': 'Medicine', 'investigatorAffiliation': 'National University Hospital, Singapore'}}}}