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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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Progression of T2DM is widely accepted to be contributed by two main components: beta cell function deterioration where insulin secretion is impaired and insulin resistance where insulin physiological response is reduced. Insulin resistance and beta cell function will be estimated through a mathematical model, homeostasis model assessment. Fasting insulin and C-peptide will be measured using liquid chromatography tandem mass spectrometry. Insulin resistance and beta cell function is then compared with the glycaemic control, HbA1C.
Primary objective
• To investigate the association between the estimation of insulin resistance and beta cell function through homeostasis model assessment with HbA1C among oral anti-diabetics treatment non-responder.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Patients who are on either metformin 2g per day or metformin extended release 2g per day. Subject will be required to fast overnight. Fasting insulin levels and plasma drug levels will be measured. |
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| Metformin + Gliclazide | Patient who are on both metformin 2g per day or metformin extended release 2g per day and gliclazide 320mg per day or gliclazide modified release 120mg per day. Subject will be required to fast overnight. Fasting insulin levels and plasma drug levels will be measured. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting insulin level | Diagnostic Test | Fasting insulin and C-peptide level measured using LCMS which is then used to calculate the insulin resistance and beta cell function using homeostasis model assessment |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA estimation of insulin resistance and beta cell function | Insulin resistance and beta cell function is estimated through homeostasis model assessment | 1 day |
| HbA1C | Glycaemic control of subjects assessed through HbA1C | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Assessed using Malaysian Medication Adherence Scale | 1 day |
| Plasma metformin level | Measured using LCMS | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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All T2DM patients under Sarawak General Hospital, Sarawak Heart Centre, Tanah Puteh Health Clinic, Jalan Masjid Health Clinic and Petra Jaya Health Clinic follow up during the period 3 July 2017 until 30 March 2018
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| Name | Affiliation | Role |
|---|---|---|
| Aylwin Ming Wee Lim | Clinical Research Centre, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre, Sarawak General Hospital | Kuching | Sarawak | 93586 | Malaysia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Blood plasma serum
| Plasma drug level | Diagnostic Test | Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance. |
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| Plasma gliclazide level | Measured using LCMS | 1 day |
| Cardiovascular risk estimation | Framingham risk score and ASCVD risk estimation | 1 day |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |