Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics

NCT ID: NCT03196154

Last Updated: 2018-07-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-03-30

Brief Summary

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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.

Detailed Description

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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

* 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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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type 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

Plasma drug level

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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

Plasma drug level

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Plasma drug level

Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Previously diagnosed to have T2DM, currently treated with oral anti-diabetics agents (either on maximum dose of Metformin only or with maximum dose of Gliclazide) for at least 3 months with no change in medications and dosage during the period of 3 months

Exclusion Criteria

* Patient that is on exogenous insulin, is on hormone replacement therapy or any steroids medications, with renal impairment with creatinine clearance less than 30ml/min and unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

Clinical Research Centre, Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Aylwin Lim Ming Wee

Research Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Malaysia

Other Identifiers

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NMRR-17-122-33927

Identifier Type: -

Identifier Source: org_study_id

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