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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Diagnostic Test: Fasting insulin level; Diagnostic Test: Plasma drug level

• Registration Number: NCT03196154
• Lead Sponsor: Clinical Research Centre, Malaysia

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2017-08-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metformin	Plasma drug level	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.
Metformin + Gliclazide	Plasma drug level	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.
Metformin	Fasting insulin level	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.
Metformin + Gliclazide	Fasting insulin level	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.

Primary Outcome Measures

Name	Time	Method
HOMA estimation of insulin resistance and beta cell function	1 day	Insulin resistance and beta cell function is estimated through homeostasis model assessment
HbA1C	1 day	Glycaemic control of subjects assessed through HbA1C

Secondary Outcome Measures

Name	Time	Method
Plasma gliclazide level	1 day	Measured using LCMS
Medication adherence	1 day	Assessed using Malaysian Medication Adherence Scale
Plasma metformin level	1 day	Measured using LCMS
Cardiovascular risk estimation	1 day	Framingham risk score and ASCVD risk estimation

Trial Locations

Locations (1)

Clinical Research Centre, Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia