New IR Biomarkers (Myokines) in Colombian People

NCT03244449 | Completed DMC

• 1 other identifier: 120465745008
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Keywords

biomarker; insulin resistance; myokine; clamp

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Once in every participant (Cross-sectional). Participants assessed over 6-months

Secondary Outcomes (1)

• HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

  Once in every participant (Cross-sectional). Participants assessed over 6-months

Interventions

No apply OTHER

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Los Andes, Columbia: lead
• The Administrative Department of Science, Technology and Innovation, Colciencias: collaborator
• Universidad Militar Nueva Granada: collaborator

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Carlos O Mendivil, MD PhD

  University of Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: August 26, 2014
• Primary Completion: October 30, 2016
• Study Completion: December 16, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08