NCT03196154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

June 19, 2017

Last Update Submit

July 17, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Homeostasis Model AssessmentInsulin ResistanceBeta Cell FunctionLiquid Chromatography Tandem Mass Spectrometry

Outcome Measures

Primary Outcomes (2)

  • HOMA estimation of insulin resistance and beta cell function

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

    1 day

  • HbA1C

    Glycaemic control of subjects assessed through HbA1C

    1 day

Secondary Outcomes (4)

  • Medication adherence

    1 day

  • Plasma metformin level

    1 day

  • Plasma gliclazide level

    1 day

  • Cardiovascular risk estimation

    1 day

Study Arms (2)

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 levelDiagnostic Test: Plasma drug level

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 levelDiagnostic Test: Plasma drug level

Interventions

Fasting insulin levelDIAGNOSTIC_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

MetforminMetformin + Gliclazide
Plasma drug levelDIAGNOSTIC_TEST

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

MetforminMetformin + Gliclazide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Aylwin Ming Wee Lim

    Clinical Research Centre, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Pharmacist

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 22, 2017

Study Start

August 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)