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

Healthy Lifestyle Clinical Trial

Official title:

Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010370
• Other study ID #: PREDIM-insulin sensitivity
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2020
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle
• Hypersensitivity
• Insulin Resistance

Locations

Country	Name	City	State
Mexico	Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity With PREDIM (PREDIcted M) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the PREDIM index.; Insulin sensitivity was calculated with PREDIM index: A + B × log_e (OGIS) + C × log_e (IMC) + D × log_e (2hGlu) + log_e (INSf). A higher result is better.; In the formula A=2.8846219; B=0.5208520; OGIS=1/2 x (B + sqrt (Bˆ2 + 4 x p5 x p6 (G120 - Gcl) x Cl OGTT)); C=-0.8223363; D=-0.4191242; E=-0.2427896; INSf=fasting insulin.	Baseline
Primary	Insulin Sensitivity With McAuley Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the McAuley index.; Insulin sensitivity was calculated with McAuley index: e[2.63-0.28 In(Insulin minute 0) - 0.31 In(Triglycerides minute 0)]. A lower result is better.	Baseline
Primary	Insulin Sensitivity With Belfiore Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Belfiore index.; Insulin sensitivity was calculated with Belfiore index: 2/((glucose minute 0/glucose minute 120) (Insulin minute 0/Insulin minute 120))+1. A higher result is better.	Baseline
Primary	Insulin Sensitivity With Cederholm Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Cederholm index.; Insulin sensitivity was calculated with Cederholm index: (75000+(Glucose minute 0- Glucose minute 120) x 19 x weight) / ((AUC Glucose/18) x log (AUC insulin/120)). A lower result is better.; In the formula AUC=area under the curve.	Baseline
Primary	Insulin Sensitivity With Avignon Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Avignon index.; Insulin sensitivity was calculated with Avignon index: ((0.137 x Sib) + Si2h)/2. A higher result is better.; In the formula Sib=10ˆ8 / ((insulin minute 0) x (glucose minute 0) x (VD=150 ml/kg of Body weight)); Si2h=10ˆ8 / ((insulin minute 120) x (glucose minute 120) x (VD=150 ml/kg of Body weight)).	Baseline
Primary	Insulin Sensitivity With Matsuda Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index.; Insulin sensitivity was calculated with Matsuda index: [10,000 / vglucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better.; In the formula OGTT: oral glucose tolerance test.	Baseline
Primary	Insulin Sensitivity With Gutt Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Gutt index.; Insulin sensitivity was calculated with Gutt index: ((75000 + (Glucose minute 0 - Glucose minute 120) x 0.10 x m) / (120 x Glucose mean x log Insulin mean). A higher result is better. A lower result is better.; In the formula m=body weight	Baseline
Primary	Insulin Sensitivity With Stumvoll Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Stumvoll index.; Insulin sensitivity was calculated with Stumvoll index: 0.156 - 0.0000459 × Insulin minute 120 - 0.000321 × Insulin minute 0 - 0.00541 × Glucose minute 120. A lower result is better.	Baseline
Primary	Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the HOMA-IR index.; Insulin sensitivity was calculated with HOMA-IR index: (Glucose minute 0) (Insulin minute 0) / 22.5. A lower result is better.	Baseline
Primary	Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the ISI index.; Insulin sensitivity was calculated with ISI index: 10000 / (Insulin minute 0) (Glucose minute 0). A lower result is better.	Baseline
Primary	Insulin Sensitivity With Raynaud Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Raynaud index.; Insulin sensitivity was calculated with Raynaud index: 40 / (Fasting insulin). a lower result is better.	Baseline
Primary	Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the QUICKI index.; Insulin sensitivity was calculated with QUICKI index: 1 / (log fasting insulin) + (log fasting glucose). A lower result is better.	Baseline
Primary	Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the FIRI index.; Insulin sensitivity was calculated with FIRI index: (Fasting Insulin) x (Fasting Glucose) / 25. A lower result is better.	Baseline
Primary	Insulin Sensitivity With Bennett Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Bennett index.; Insulin sensitivity was calculated with Bennett index: 1 / (log Fasting insulin) x (log Fasting glucose). A lower result is better.	Baseline
Primary	Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index	With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the TyG index.; Insulin sensitivity was calculated with TyG index: [ln (Triglycerides) x (Fasting Glucose) / 2]. A lower result is better.	Baseline