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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03196154

Acronym

InsuReB

Enrollment

255

Registered

2017-06-22

Start date

2017-08-01

Completion date

2018-03-30

Last updated

2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Homeostasis Model Assessment, Insulin Resistance, Beta Cell Function, Liquid Chromatography Tandem Mass Spectrometry

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

Interventions

DIAGNOSTIC_TESTFasting 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_TESTPlasma drug level

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026