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

Diabetes Mellitus, Type 2 Clinical Trial

— InsuReB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196154
• Other study ID #: NMRR-17-122-33927
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: July 2018
• Source: Clinical Research Centre, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
Malaysia	Clinical Research Centre, Sarawak General Hospital	Kuching	Sarawak

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA estimation of insulin resistance and beta cell function	Insulin resistance and beta cell function is estimated through homeostasis model assessment	1 day
Primary	HbA1C	Glycaemic control of subjects assessed through HbA1C	1 day
Secondary	Medication adherence	Assessed using Malaysian Medication Adherence Scale	1 day
Secondary	Plasma metformin level	Measured using LCMS	1 day
Secondary	Plasma gliclazide level	Measured using LCMS	1 day
Secondary	Cardiovascular risk estimation	Framingham risk score and ASCVD risk estimation	1 day