Clinical trial NCT03196154: Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Homeostasis Model Assessment
Insulin Resistance
Beta Cell Function
Liquid Chromatography Tandem Mass Spectrometry
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2017-06-22
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All T2DM patients under Sarawak General Hospital, Sarawak Heart Centre, Tanah Puteh Health Clinic, Jalan Masjid Health Clinic and Petra Jaya Health Clinic follow up during the period 3 July 2017 until 30 March 2018

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

Eligibility criteria: 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

Primary outcomes:
measure: HOMA estimation of insulin resistance and beta cell function
timeFrame: 1 day
measure: HbA1C
timeFrame: 1 day
Secondary outcomes:
measure: Medication adherence
timeFrame: 1 day
measure: Plasma metformin level
timeFrame: 1 day
measure: Plasma gliclazide level
timeFrame: 1 day
measure: Cardiovascular risk estimation
timeFrame: 1 day
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Clinical Research Centre, Sarawak General Hospital
state: Sarawak
Study officials:
affiliation: Clinical Research Centre, Malaysia
name: Aylwin Ming Wee Lim
role: PRINCIPAL_INVESTIGATOR
References: