Clinical trial NCT04010370: Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index
Official title: Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Lifestyle
Keywords: Insulin sensitivity
PREDIM
Correlation
Healthy individuals
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes who are not sedentary or who participate in heavy physical activities and residents of the metropolitan area of Guadalajara.

Brief summary: Recently, an index based on the oral insulin sensitivity index with glucose (OGIS) has been proposed in combination with anthropometric variables, called PREDIcted M (PREDIM), however, there is no evidence of the correlation of this with respect to the various indices (McAuley, Belfiore, Cederholm, Avignon, Matsuda, Gutt, Stumvoll, HOMA-IR (Homeostatic Model Assessment for Insulin Resistance), ISI (Insulin Sensitivity Index), Raynaud, QUICKI (The quantitative insulin sensitivity check index), FIRI (Fasting Insulin Resistance Index), Bennett, TyG (triglycerides and glucose index)) in healthy patients.

Detailed description: Analytical cross-sectional study with 25 healthy patients of both genders (male and female) from 30 to 60 years old, residents of the metropolitan area of Guadalajara.

They will be operated on for a 3-hour oral glucose tolerance test. The insulin sensitivity will be calculated with the PREDIM, Matsuda, McAuley, Belfiore, Cederholm, Avignon, Gutt, Stumvoll, HOMA-IR, ISI, Raynaud, QUICKI, FIRI, Bennett and TyG indexes.

This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

The statistical analysis will be presented with measures of central tendency and dispersion, mean and standard deviation. The nominal variables in numbers and percentages. The Kolmogorov-Smirnov test will be performed to determine if the variables follow a normal distribution. To correlate the formulas used to evaluate the insulin sensitivity with the PREDIcted M (PREDIM) technique, the Pearson or Spearman correlation will be used according to the distribution.

Eligibility criteria: Inclusion Criteria:

* Both genres
* Age 30 to 60 years
* BMI \<25 kg / m2,
* Patients who are not sedentary or who participate in heavy physical activities
* Stable weight in the last 3 months

Exclusion Criteria:

* Blood pressure \>120/80 mmHg
* Glucose \>100 mg/dL
* Postprandial glucose \>140 mg/dL
* Cholesterol \>200 mg/dL
* Triglycerides \>150 mg/dL
* Smoking
* Women with polycystic ovarian syndrome
* History of metabolic, cardiovascular, thyroid, renal, pancreatic and/or arterial hypertension
* Use of medications that modify insulin sensitivity (corticosteroids)
* Previous surgery or infection
* Symptoms of vomiting and/or excessive nausea

Primary outcomes:
measure: Insulin Sensitivity With PREDIM (PREDIcted M) Index
timeFrame: Baseline
measure: Insulin Sensitivity With McAuley Index
timeFrame: Baseline
measure: Insulin Sensitivity With Belfiore Index
timeFrame: Baseline
measure: Insulin Sensitivity With Cederholm Index
timeFrame: Baseline
measure: Insulin Sensitivity With Avignon Index
timeFrame: Baseline
measure: Insulin Sensitivity With Matsuda Index
timeFrame: Baseline
measure: Insulin Sensitivity With Gutt Index
timeFrame: Baseline
measure: Insulin Sensitivity With Stumvoll Index
timeFrame: Baseline
measure: Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index
timeFrame: Baseline
measure: Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index
timeFrame: Baseline
measure: Insulin Sensitivity With Raynaud Index
timeFrame: Baseline
measure: Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index
timeFrame: Baseline
measure: Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index
timeFrame: Baseline
measure: Insulin Sensitivity With Bennett Index
timeFrame: Baseline
measure: Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara.
name: Manuel Gonzalez Ortiz, PhD
role: PRINCIPAL_INVESTIGATOR
References: