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Trial record 4 of 4 for:    DIABETES | TANDEM

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

This study is currently recruiting participants.
Verified September 2017 by Aylwin Lim Ming Wee, Clinical Research Centre, Malaysia
Sponsor:
ClinicalTrials.gov Identifier:
NCT03196154
First Posted: June 22, 2017
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Aylwin Lim Ming Wee, Clinical Research Centre, Malaysia
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Diagnostic Test: Fasting insulin level Diagnostic Test: Plasma drug level

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Aylwin Lim Ming Wee, Clinical Research Centre, Malaysia:

Primary Outcome Measures:
  • 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

  • HbA1C [ Time Frame: 1 day ]
    Glycaemic control of subjects assessed through HbA1C


Secondary Outcome Measures:
  • Medication adherence [ Time Frame: 1 day ]
    Assessed using Malaysian Medication Adherence Scale

  • Plasma metformin level [ Time Frame: 1 day ]
    Measured using LCMS

  • Plasma gliclazide level [ Time Frame: 1 day ]
    Measured using LCMS

  • Cardiovascular risk estimation [ Time Frame: 1 day ]
    Framingham risk score and ASCVD risk estimation


Biospecimen Retention:   Samples Without DNA
Blood plasma serum

Estimated Enrollment: 250
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: March 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metformin
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.
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.
Metformin + Gliclazide
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.
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196154


Contacts
Contact: Aylwin Ming Wee Lim +6082276820 ext 511 aylwin.lim.11@alumni.ucl.ac.uk

Locations
Malaysia
Clinical Research Centre, Sarawak General Hospital Recruiting
Kuching, Sarawak, Malaysia, 93586
Contact: Aylwin Ming Wee Lim    +6082276820 ext 511    aylwin.lim.11@alumni.ucl.ac.uk   
Sponsors and Collaborators
Clinical Research Centre, Malaysia
Ministry of Health, Malaysia
Investigators
Principal Investigator: Aylwin Ming Wee Lim Clinical Research Centre, Malaysia
  More Information

Responsible Party: Aylwin Lim Ming Wee, Research Pharmacist, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT03196154     History of Changes
Other Study ID Numbers: NMRR-17-122-33927
First Submitted: June 19, 2017
First Posted: June 22, 2017
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aylwin Lim Ming Wee, Clinical Research Centre, Malaysia:
Homeostasis Model Assessment
Insulin Resistance
Beta Cell Function
Liquid Chromatography Tandem Mass Spectrometry

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Insulin
Metformin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs