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

Completed

• Conditions: Diabetes Mellitus, Type 2

• 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Plasma gliclazide level	1 day	Measured using LCMS

Trial Locations

Locations (1)

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