Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics
NCT ID: NCT03196154
Last Updated: 2018-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2017-08-01
2018-03-30
Brief Summary
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Detailed Description
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• 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
* To compare the insulin resistance and beta cell function between the OAD treatment responders (negative control) and non-responders
* To investigate the relationship between plasma level of metformin and gliclazide with the estimation of beta cell function and insulin resistance
* To identify the proportion of patients with high insulin resistance and proportion of patients with low beta cell function
* To identify difference in insulin resistance and beta cell function of different ethnic groups in Sarawak
* To compare insulin resistance with cardiovascular disease risk using Framingham Risk Score and ASCVD risk estimation
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
Fasting insulin level
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
Plasma drug level
Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.
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.
Fasting insulin level
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
Plasma drug level
Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.
Interventions
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Fasting insulin level
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
Plasma drug level
Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ministry of Health, Malaysia
OTHER_GOV
Clinical Research Centre, Malaysia
OTHER
Responsible Party
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Aylwin Lim Ming Wee
Research Pharmacist
Principal Investigators
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Aylwin Ming Wee Lim
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Centre, Malaysia
Locations
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Clinical Research Centre, Sarawak General Hospital
Kuching, Sarawak, Malaysia
Countries
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Other Identifiers
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NMRR-17-122-33927
Identifier Type: -
Identifier Source: org_study_id
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