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Completed

NCT Number: NCT04010370

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

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.

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Key information

Conditions

Healthy Lifestyle Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Insulin Sensitivity With PREDIM (PREDIcted M) Index

    Time frame: Baseline

    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.

  2. Insulin Sensitivity With McAuley Index

    Time frame: Baseline

    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.

  3. Insulin Sensitivity With Belfiore Index

    Time frame: Baseline

    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.

  4. Insulin Sensitivity With Cederholm Index

    Time frame: Baseline

    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.

  5. Insulin Sensitivity With Avignon Index

    Time frame: Baseline

    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)).

  6. Insulin Sensitivity With Matsuda Index

    Time frame: Baseline

    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 / √glucose 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.

  7. Insulin Sensitivity With Gutt Index

    Time frame: Baseline

    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

  8. Insulin Sensitivity With Stumvoll Index

    Time frame: Baseline

    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.

  9. Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index

    Time frame: Baseline

    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.

  10. Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index

    Time frame: Baseline

    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.

  11. Insulin Sensitivity With Raynaud Index

    Time frame: Baseline

    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.

  12. Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index

    Time frame: Baseline

    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.

  13. Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index

    Time frame: Baseline

    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.

  14. Insulin Sensitivity With Bennett Index

    Time frame: Baseline

    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.

  15. Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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