Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.

Official Title
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Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance

Conditions
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Type 2 Diabetes Mellitus, PreDiabetes

Intervention / Treatment
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* Drug: Sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study Subjects who are willing to participate and sign the informed consent form Exclusion Criteria: Patients with pre-existing T2DM Patients with family history of diabetes Patients receiving glucose-lowering medications Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low GLP-1 arm<br>Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin | Drug: Sitagliptin<br>* oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.<br>|
| Active Comparator: normal GLP-1 arm<br>Subjects are required to take oral 100mg Sitagliptin ( Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin | Drug: Sitagliptin<br>* oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood glucose load response to sitagliptin | change from blood glucose response at 12 weeks | pre-treatment of sitagliptin and post 12-week treatment of sitagliptin | 
| change in blood insulin response to sitagliptin | change from blood insulin response at 12 weeks | pre-treatment of sitagliptin and post 12-week treatment of sitagliptin |