New IR Biomarkers (Myokines) in Colombian People

August 8, 2017 updated by: Carlos O Mendivil, University of Los Andes, Columbia

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults of both sexes, aged between 35 and 65 years, without any significant comorbidity

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Once in every participant (Cross-sectional). Participants assessed over 6-months
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)
Once in every participant (Cross-sectional). Participants assessed over 6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Time Frame: Once in every participant (Cross-sectional). Participants assessed over 6-months
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.
Once in every participant (Cross-sectional). Participants assessed over 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Los Andes, Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Administrative Department of Science, Technology and Innovation, Colciencias
Universidad Militar Nueva Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos O Mendivil, MD PhD, University of Los Andes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 120465745008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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