Insulin ResistanceNCT03244449
New IR Biomarkers (Myokines) in Colombian People
An observational study of Insulin Resistance and Diabetes Mellitus, Type 2, run by University of Los Andes, Columbia.
Trial summary
Around the world, the prevalence of type 2 diabetes mellitus (T2DM) has been increasing since the last two decades, with approximately 347 million patients with diabetes by 2013 according to the World Health Organization (WHO). Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Diabetes Mellitus, Type 2
- What is being tested?
- No apply
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2014to 16 Dec 2016
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults of both sexes, aged between 35 and 65 years, without any significant comorbidity
Who may be able to join
- Age between 35-65 years
- Diligence of informed consent
- Absence of acute illness
- Body mass index less or greater than 25 kg/m2, and presence or absence of a previous diagnosis of diabetes according to the criteria previously stated.
Who cannot join
- Current therapy with insulin
- Type 1 diabetes
- Oral or injectable anticoagulation
- Previous diagnosis of insulinoma, insulinomatosis, glucagonoma, or other neoplastic disorders of the endocrine pancreas.
- Pregnant women
- BMI <18.5 kg / m2
About this study
Official title: Identification and Validation of Myonectin, Myostatin and FGF-21 as Insulin Resistance Biomarkers in Colombian People
Around the world, the prevalence of type 2 diabetes mellitus (T2DM) has been increasing since the last two decades, with approximately 347 million patients with diabetes by 2013 according to the World Health Organization (WHO). This pronounced increase is due to an increase in the prevalence of obesity, reduction in physical activity levels, accelerated urbanization and aging of the population. In Colombia, T2DM ranks fifth in the main morbidity and mortality causes, including only deaths caused directly and without adding the strong influence that T2DM has on cardiovascular disease mortality.
Insufficient tissue response to normal insulin concentrations, called insulin resistance, is one of the central pathophysiological mechanisms in the development of T2DM. However, there is currently no simple, practical, safe and reproducible method that allows the diagnosis or identification of insulin resistance, nor the follow-up to its evolution. At the moment, the gold standard for assessing the degree of insulin sensitivity or resistance is the "hyperinsulinemic-euglycemic clamp", a laborious technique, of high cost and high technical difficulty, requiring specialized personnel and hospitalization. Non-invasive methods based on mathematical regressions, such as the Homeostatic Model Assessment (HOMA-IR), are imperfect and widely variable, and have not been validated in the Latin American population, less Still Colombian.
Read more
Therefore, the development of new, easily obtainable quantitative tools for the diagnosis of insulin resistance is required. This requires not only the identification of new and better biomarkers, but also the determination of their diagnostic performance and operational characteristics.
This project will investigate 3 molecular targets (myokines), novel and easy to measure, with high probability of being good biomarkers of insulin resistance. The research will include validation of its association with insulin resistance measured by the reference method, as well as its measurement in apparently healthy individuals. Finally, operator-receiver characteristics of each test will be analyzed, in order to propose a cutoff point for the diagnosis of insulin resistance.
Read the detailed description
The objectives of the project are: 1) To identify, within a group of 3 potential new biomarkers of insulin resistance, those that are significantly associated with the presence of this phenomenon in our population, 2) Establish, analyze and apply reference values for each one of these three biomarkers in Colombian population. 3) To evaluate the sensitivity, specificity, statistical C (operational performance), predictive values and likelihood ratios of each of the biomarkers studied for the diagnosis of insulin resistance versus a standard gold technique and 4) Different biomarkers evaluated, in order to select the best one (s) for clinical use, as well as to propose a cutoff point for detection of insulin resistance for each of them.
Methodology: A cross-sectional, diagnostic test evaluation study will be conducted, including apparently healthy Adults of both sexes, with ages between 35 and 65 years, coming from Bogotá, without any significant comorbidity.
As initial evaluation will be carried out measurement of height, weight, percentage of body fat, blood pressure, diet questionnaire, physical activity and sociocultural characteristics. For patients with prediabetes and T2DM, the time elapsed since the diagnosis will be obtained, as well as information about pharmacological or non-pharmacological treatment that they are receiving.
For the serological evaluation, a sample of venous blood should be taken in the fasted state, with the aim of measuring the following markers: Fibroblast Growth Factor 21 (FGF21) , Myonectin, and Myostatin. In addition to routine tests such as fasting glycemia, glycosylated hemoglobin, fasting insulinemia, lipid profile (total cholesterol, HDL cholesterol, triglycerides, LDL-C) and C-reactive protein. Additionally, all subjects will participate in an oral glucose tolerance test (OGTT).
In addition to the gold standard of measurement of insulin resistance (hyperinsulinemic-euglycemic clamp), six of the tools currently available for the search of insulin resistance, all derived from calculations from the measurements of The HOMA beta-cell function (HOMA beta-cell%), insulin sensitivity index (ISI), index 1 / fasting insulin, corrected insulin response, insulin / glucose ratio and insulinemia Of fasting.
For each biomarker, an operator / receiver characteristics curve (ROC curve) will be calculated, calculating diagnostic performance and cutoff points with the best combination of sensitivity and specificity. A first approximation will be made to baseline values for these tests, based on the distribution of the tests in healthy, and one or more insulin resistance biomarkers with their recommended cutoff points will be proposed.
- Conditions
- Insulin Resistance, Diabetes Mellitus, Type 2
- Being tested
- No apply
- Keywords
- biomarker, insulin resistance, myokine, clamp
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No applyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the insulin curve (iAUCins)
Area under the insulin curve in a 5-point oral glucose tolerance test, calculated with the trapezoid method, a reliable indicator of whole-body insulin resistance. Expressed in mg*(dL^-1)*(h^-1)
Measured: Once in every participant (Cross-sectional). Participants assessed over 6-months
Whole-body glucose disposal
Glucose disposal when steady state is reached in a hyperinsulinemic-euglycemic clamp, the gold-standard measure of whole-body insulin sensitivity. Expressed in mg*(Kg^-1)*(min^-1)
Measured: Once in every participant (Cross-sectional). Participants assessed over 6-months
Secondary outcomes (1)
HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Product of the fasting glycemia in mmol/L and fasting insulinemia in microunits/mL, a surrogate measure of insulin resistance, especially in the fasting state.
Measured: Once in every participant (Cross-sectional). Participants assessed over 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start26 Aug 2014
- Primary completion30 Oct 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Los Andes, Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Administrative Department of Science, Technology and Innovation, Colciencias, Universidad Militar Nueva Granada
- Responsible party
- Principal investigator, Carlos O Mendivil, University of Los Andes, Columbia
- Investigators
- Carlos O Mendivil, MD PhD, Principal investigator, University of Los Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244449
- Sponsor's protocol ID
- 120465745008
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Myonectin, Myostatin and FGF-21 as Insulin Resistance Biomarkers in Colombian People
- ClinicalTrials.gov ID
- NCT03244449
- Acronym / sponsor ID
- 120465745008
- Conditions
- Insulin Resistance, Diabetes Mellitus, Type 2
- Keywords
- biomarker, insulin resistance, myokine, clamp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Los Andes, ColumbiaUniversity, hospital or other
- Collaborators
- The Administrative Department of Science, Technology and Innovation, Colciencias, Universidad Militar Nueva Granada
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 9 Aug 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.
Around the world, the prevalence of type 2 diabetes mellitus (T2DM) has been increasing since the last two decades, with approximately 347 million patients with diabetes by 2013 according to the World Health Organization (WHO). This pronounced increase is due to an increase in the prevalence of obesity, reduction in physical activity levels, accelerated urbanization and aging of the population. In Colombia, T2DM ranks fifth in the main morbidity and mortality causes, including only deaths caused directly and without adding the strong influence that T2DM has on cardiovascular disease mortality.
Insufficient tissue response to normal insulin concentrations, called insulin resistance, is one of the central pathophysiological mechanisms in the development of T2DM. However, there is currently no simple, practical, safe and reproducible method that allows the diagnosis or identification of insulin resistance, nor the follow-up to its evolution. At the moment, the gold standard for assessing the degree of insulin sensitivity or resistance is the "hyperinsulinemic-euglycemic clamp", a laborious technique, of high cost and high technical difficulty, requiring specialized personnel and hospitalization. Non-invasive methods based on mathematical regressions, such as the Homeostatic Model Assessment (HOMA-IR), are imperfect and widely variable, and have not been validated in the Latin American population, less Still Colombian.
Therefore, the development of new, easily obtainable quantitative tools for the diagnosis of insulin resistance is required. This requires not only the identification of new and better biomarkers, but also the determination of their diagnostic performance and operational characteristics.
This project will investigate 3 molecular targets (myokines), novel and easy to measure, with high probability of being good biomarkers of insulin resistance. The research will include validation of its association with insulin resistance measured by the reference method, as well as its measurement in apparently healthy individuals. Finally, operator-receiver characteristics of each test will be analyzed, in order to propose a cutoff point for the diagnosis of insulin resistance.
Detailed description
The objectives of the project are: 1) To identify, within a group of 3 potential new biomarkers of insulin resistance, those that are significantly associated with the presence of this phenomenon in our population, 2) Establish, analyze and apply reference values for each one of these three biomarkers in Colombian population. 3) To evaluate the sensitivity, specificity, statistical C (operational performance), predictive values and likelihood ratios of each of the biomarkers studied for the diagnosis of insulin resistance versus a standard gold technique and 4) Different biomarkers evaluated, in order to select the best one (s) for clinical use, as well as to propose a cutoff point for detection of insulin resistance for each of them.
Methodology: A cross-sectional, diagnostic test evaluation study will be conducted, including apparently healthy Adults of both sexes, with ages between 35 and 65 years, coming from Bogotá, without any significant comorbidity.
As initial evaluation will be carried out measurement of height, weight, percentage of body fat, blood pressure, diet questionnaire, physical activity and sociocultural characteristics. For patients with prediabetes and T2DM, the time elapsed since the diagnosis will be obtained, as well as information about pharmacological or non-pharmacological treatment that they are receiving.
For the serological evaluation, a sample of venous blood should be taken in the fasted state, with the aim of measuring the following markers: Fibroblast Growth Factor 21 (FGF21) , Myonectin, and Myostatin. In addition to routine tests such as fasting glycemia, glycosylated hemoglobin, fasting insulinemia, lipid profile (total cholesterol, HDL cholesterol, triglycerides, LDL-C) and C-reactive protein. Additionally, all subjects will participate in an oral glucose tolerance test (OGTT).
In addition to the gold standard of measurement of insulin resistance (hyperinsulinemic-euglycemic clamp), six of the tools currently available for the search of insulin resistance, all derived from calculations from the measurements of The HOMA beta-cell function (HOMA beta-cell%), insulin sensitivity index (ISI), index 1 / fasting insulin, corrected insulin response, insulin / glucose ratio and insulinemia Of fasting.
For each biomarker, an operator / receiver characteristics curve (ROC curve) will be calculated, calculating diagnostic performance and cutoff points with the best combination of sensitivity and specificity. A first approximation will be made to baseline values for these tests, based on the distribution of the tests in healthy, and one or more insulin resistance biomarkers with their recommended cutoff points will be proposed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults of both sexes, aged between 35 and 65 years, without any significant comorbidity
Key inclusion criteria (4 listed)
- Age between 35-65 years
- Diligence of informed consent
- Absence of acute illness
- Body mass index less or greater than 25 kg/m2, and presence or absence of a previous diagnosis of diabetes according to the criteria previously stated.
Key exclusion criteria (6 listed)
- Current therapy with insulin
- Type 1 diabetes
- Oral or injectable anticoagulation
- Previous diagnosis of insulinoma, insulinomatosis, glucagonoma, or other neoplastic disorders of the endocrine pancreas.
- Pregnant women
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 |
|---|---|---|
| No apply | Other | – |
Primary outcome
Incremental area under the insulin curve (iAUCins)
Time frame: Once in every participant (Cross-sectional). Participants assessed over 6-months
Area under the insulin curve in a 5-point oral glucose tolerance test, calculated with the trapezoid method, a reliable indicator of whole-body insulin resistance. Expressed in mg*(dL^-1)*(h^-1)
Whole-body glucose disposal
Time frame: Once in every participant (Cross-sectional). Participants assessed over 6-months
Glucose disposal when steady state is reached in a hyperinsulinemic-euglycemic clamp, the gold-standard measure of whole-body insulin sensitivity. Expressed in mg*(Kg^-1)*(min^-1)
1 secondary outcome
HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Time frame: Once in every participant (Cross-sectional). Participants assessed over 6-months
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 9 Aug 2017.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Carlos O Mendivil, MD PhD principal investigator
University of Los Andes
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Diabetes Mellitus, Type 2, run by University of Los Andes, Columbia.
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 4 inclusion and 6 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incremental area under the insulin curve (iAUCins) (time frame: Once in every participant (Cross-sectional). Participants assessed over 6-months). 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 9 Aug 2017.