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

Clinical Research Centre, Malaysia

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Diagnostic Test: Fasting insulin level; Diagnostic Test: Plasma drug level

Study type: Observational

Funder types: Other

Identifiers

NCT03196154

NMRR-17-122-33927

Details and patient eligibility

About

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.

Full 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

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

255 participants in 2 patient groups

Metformin

Description:

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.

Treatment:

Diagnostic Test: Fasting insulin level

Diagnostic Test: Plasma drug level

Metformin + Gliclazide

Description:

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.

Treatment:

Diagnostic Test: Fasting insulin level

Diagnostic Test: Plasma drug level