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Completed

NCT Number: NCT03196154

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Centre, Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting insulin level

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. HOMA estimation of insulin resistance and beta cell function

    Time frame: 1 day

    Insulin resistance and beta cell function is estimated through homeostasis model assessment

  2. HbA1C

    Time frame: 1 day

    Glycaemic control of subjects assessed through HbA1C

Secondary outcomes

  1. Medication adherence

    Time frame: 1 day

    Assessed using Malaysian Medication Adherence Scale

  2. Plasma metformin level

    Time frame: 1 day

    Measured using LCMS

  3. Plasma gliclazide level

    Time frame: 1 day

    Measured using LCMS

  4. Cardiovascular risk estimation

    Time frame: 1 day

    Framingham risk score and ASCVD risk estimation

Sponsors and collaborators

Lead sponsor

Clinical Research Centre, Malaysia

Other

Collaborators

  • Ministry of Health, Malaysia

Registry information

Official study 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

Acronym: InsuReB

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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