Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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.

Conditions

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Healthy Lifestyle

Keywords

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Insulin sensitivity PREDIM Correlation Healthy individuals

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy individuals

Cross-Sectional. No intervention. Patients of both sexes who are not sedentary or who participate in heavy physical activities and residents of the metropolitan area of Guadalajara

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Manuel González Ortiz

Researcher Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Gonzalez Ortiz, PhD

Role: PRINCIPAL_INVESTIGATOR

Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara.

Locations

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Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form