Healthy Lifestyle
Conditions
Keywords
Insulin sensitivity, PREDIM, Correlation, Healthy individuals
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.
Interventions
None listed
Sponsors
University of Guadalajara
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity With PREDIM (PREDIcted M) Index | 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. |
| Insulin Sensitivity With McAuley Index | 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. |
| Insulin Sensitivity With Belfiore Index | 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. |
| Insulin Sensitivity With Bennett Index | 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. |
| Insulin Sensitivity With Cederholm Index | 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. |
| Insulin Sensitivity With Avignon Index | 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)). |
| Insulin Sensitivity With Matsuda Index | 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. |
| Insulin Sensitivity With Gutt Index | 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 |
| Insulin Sensitivity With Stumvoll Index | 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. |
| Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index | 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. |
| Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index | 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. |
| Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index | 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. |
| Insulin Sensitivity With Raynaud Index | 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. |
| Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index | 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. |
| Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Individuals 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Healthy Individuals |
|---|---|
| Age, Continuous | 32.44 Years STANDARD_DEVIATION 2.79 |
| Body mass index (BMI) | 22.42 kg/m^2 STANDARD_DEVIATION 1.75 |
| Body weight | 62.2 kg STANDARD_DEVIATION 9.1 |
| Creatinine | 78.7 mmol/L STANDARD_DEVIATION 23.9 |
| Diastolic blood pressure | 71.36 mmHg STANDARD_DEVIATION 6.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fasting glucose | 4.58 mmol/L STANDARD_DEVIATION 0.41 |
| Region of Enrollment Mexico | 25 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 8 Participants |
| Systolic blood pressure | 105.6 mmHg STANDARD_DEVIATION 9.72 |
| Total cholesterol | 4.5 mmol/L STANDARD_DEVIATION 0.5 |
| Triglycerides | 0.82 mmol/L STANDARD_DEVIATION 0.29 |
| Uric acid | 273.01 mmol/L STANDARD_DEVIATION 69.59 |
| Waist circumference | 78.88 cm STANDARD_DEVIATION 7.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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)).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Avignon Index | 271.11 index | Standard Deviation 115.37 |
Comparison: Correlation of Avignon index with PREDIM index at baseline.p-value: 0.246Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Belfiore Index | 1.52 index | Standard Deviation 0.194 |
Comparison: Correlation of Belfiore index with PREDIM index at baseline.p-value: 0.319Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Bennett Index | 0.64 index | Standard Deviation 0.15 |
Comparison: Correlation of Bennett index with PREDIM index at baseline.p-value: 0.726Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Cederholm Index | 153.25 index | Standard Deviation 38.93 |
Comparison: Correlation of Cederholm index with PREDIM index at baseline.p-value: 0.27Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index | 26.13 index | Standard Deviation 12.25 |
Comparison: Correlation of FIRI index with PREDIM index at baseline.p-value: 0.531Spearman correlation
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Gutt Index | 79.99 index | Standard Deviation 16.5 |
Comparison: Correlation of Gutt index with PREDIM index at baseline.p-value: 0.69Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index | 1.61 index | Standard Deviation 0.76 |
Comparison: Correlation of HOMA-IR index with PREDIM index at baseline.p-value: 0.69Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index | 18.61 index | Standard Deviation 8.3 |
Comparison: Correlation of ISI index with PREDIM index at baseline.p-value: 0.69Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Matsuda Index | 8.15 index | Standard Deviation 3.2 |
Comparison: Correlation of Matsuda index with PREDIM index at baseline.p-value: 0.259Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With McAuley Index | 46.69 index | Standard Deviation 62.28 |
Comparison: Correlation of McAuley index with PREDIM index at baseline.p-value: <0.001Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With PREDIM (PREDIcted M) Index | 72.48 index | Standard Deviation 14.47 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index | 0.36 index | Standard Deviation 0.03 |
Comparison: Correlation of QUICKI index with PREDIM index at baseline.p-value: 0.69Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Raynaud Index | 6.05 index | Standard Deviation 2.59 |
Comparison: Correlation of Raynaud index with PREDIM index at baseline.p-value: 0.541Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With Stumvoll Index | 0.1339 index | Standard Deviation 0.0242 |
Comparison: Correlation of Stumvoll index with PREDIM index at baseline.p-value: 0.022Spearman correlation
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Individuals | Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index | 1.88 index | Standard Deviation 0.08 |
Comparison: Correlation of TyG index with PREDIM index at baseline.p-value: 0.787Spearman correlation