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

Sponsor

Clinical Research Centre, Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT03196154

Collaborator

Ministry of Health, Malaysia (Other)

255

Enrollment

Location

7.9

Actual Duration (Months)

32.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Diagnostic Test: Fasting insulin level Diagnostic Test: Plasma drug level

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 Design

Study Type:

Observational

Actual Enrollment :

255 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Cross-Sectional Study on Association Between the Estimation of Insulin Resistance and Beta Cell Function Through Homeostasis Model Assessment With HbA1C Among Oral Anti-Diabetics Treatment Non-Responders

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Mar 30, 2018

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: 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 Diagnostic Test: 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.	Diagnostic Test: 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 Diagnostic Test: Plasma drug level Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.

Arm

Intervention/Treatment

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.

Diagnostic Test: 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

Diagnostic Test: 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.

Diagnostic Test: 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

Diagnostic Test: Plasma drug level

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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