NCT03196154

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
• Phase: —
• Study type: Observational
• Enrollment: 255 (actual)
• Sponsor: Clinical Research Centre, Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2017-06-22
• Last updated: 2018-07-19

Locations

1 site across 1 country: Malaysia