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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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)). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of both sexes who are not sedentary or who participate in heavy physical activities and residents of the metropolitan area of Guadalajara.
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Gonzalez Ortiz, PhD | Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Individuals | 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Individuals | 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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Through study completion, an average of 3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Individuals | Subjects of both sexes (men and women), aged 30-60 years under 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manuel González Ortiz | Institute of Experimental andl Clinical Therapeutics | +52-33-10-58-52-00 | 34212 | uiec@prodigy.net.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2018 | Sep 17, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2018 | Sep 17, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline |
| 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 / √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. | Baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fasting glucose | Fasting glucose was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Waist circumference | Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Mean | Standard Deviation | cm |
|
| Body weight | Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal. | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Body mass index was calculated as weight (kg) divided by height (m^2). | Mean | Standard Deviation | kg/m^2 |
|
| Total cholesterol | Total cholesterol was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Triglycerides were analyzed with the triglycerides oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Creatinine | Creatinine was analyzed with the alkaline picrate technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Uric acid | Uric acid was analyzed with the uric acid oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Systolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). | Mean | Standard Deviation | mmHg |
|
| Counts |
|---|
| Participants |
|
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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|
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| 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. | Posted | Mean | Standard Deviation | index | 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. | Posted | Mean | Standard Deviation | index | 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)). | Posted | Mean | Standard Deviation | index | Baseline |
|
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|
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| 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 / √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. | Posted | Mean | Standard Deviation | index | 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 | Posted | Mean | Standard Deviation | index | Baseline |
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|
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
|
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|
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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| 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. | Posted | Mean | Standard Deviation | index | Baseline |
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