Diabetes Mellitus, Type 2 Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |