Diabetes Mellitus, Type 2InsuReBNCT03196154
Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics
An observational study of Diabetes Mellitus, Type 2, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fasting insulin level and Plasma drug level
- How many people
- 255 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2017to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Clinical Research Centre, Sarawak General Hospital
Kuching, Sarawak, 93586
About this study
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
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.
Read the 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
- Being tested
- Fasting insulin level, Plasma drug level
- Keywords
- Homeostasis Model Assessment, Insulin Resistance, Beta Cell Function, Liquid Chromatography Tandem Mass Spectrometry
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Plasma drug levelDiagnostic test
Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fasting insulin level; Diagnostic 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. Receives: Diagnostic Test: Fasting insulin level; Diagnostic Test: Plasma drug level |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA estimation of insulin resistance and beta cell function
Insulin resistance and beta cell function is estimated through homeostasis model assessment
Measured: 1 day
HbA1C
Glycaemic control of subjects assessed through HbA1C
Measured: 1 day
Secondary outcomes (4)
Medication adherence
Assessed using Malaysian Medication Adherence Scale
Measured: 1 day
Plasma metformin level
Measured using LCMS
Measured: 1 day
Plasma gliclazide level
Measured using LCMS
Measured: 1 day
Cardiovascular risk estimation
Framingham risk score and ASCVD risk estimation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Aug 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Aylwin Lim Ming Wee, Clinical Research Centre, Malaysia
- Investigators
- Aylwin Ming Wee Lim, Principal investigator, Clinical Research Centre, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196154
- Sponsor's protocol ID
- NMRR-17-122-33927
- Acronym
- InsuReB
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03196154
- Acronym / sponsor ID
- InsuReB / NMRR-17-122-33927
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Homeostasis Model Assessment, Insulin Resistance, Beta Cell Function, Liquid Chromatography Tandem Mass Spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | – | Diagnostic Test: Fasting insulin level, Diagnostic Test: Plasma drug levelPatients 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. |
| Metformin + Gliclazide | – | Diagnostic Test: Fasting insulin level, Diagnostic Test: Plasma drug levelPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting insulin levelFasting 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 | Metformin, Metformin + Gliclazide |
| Plasma drug levelPlasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance. | Diagnostic test | Metformin, Metformin + Gliclazide |
Primary outcome
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
4 secondary outcomes
Medication adherence
Time frame: 1 day
Plasma metformin level
Time frame: 1 day
Plasma gliclazide level
Time frame: 1 day
Cardiovascular risk estimation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylwin Ming Wee Lim principal investigator
Clinical Research Centre, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA estimation of insulin resistance and beta cell function (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.