Trial Outcomes & Findings for Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (NCT NCT04010370)

NCT ID: NCT04010370

Last Updated: 2020-12-03

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-12-03

Participant Flow

Participant milestones

Measure	Healthy Individuals 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Age, Continuous	32.44 Years STANDARD_DEVIATION 2.79 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	25 participants n=5 Participants
Fasting glucose	4.58 mmol/L STANDARD_DEVIATION 0.41 • n=5 Participants
Waist circumference	78.88 cm STANDARD_DEVIATION 7.90 • n=5 Participants
Body weight	62.2 kg STANDARD_DEVIATION 9.1 • n=5 Participants
Body mass index (BMI)	22.42 kg/m^2 STANDARD_DEVIATION 1.75 • n=5 Participants
Total cholesterol	4.5 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants
Triglycerides	0.82 mmol/L STANDARD_DEVIATION 0.29 • n=5 Participants
Creatinine	78.7 mmol/L STANDARD_DEVIATION 23.9 • n=5 Participants
Uric acid	273.01 mmol/L STANDARD_DEVIATION 69.59 • n=5 Participants
Systolic blood pressure	105.6 mmHg STANDARD_DEVIATION 9.72 • n=5 Participants
Diastolic blood pressure	71.36 mmHg STANDARD_DEVIATION 6.53 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With PREDIM (PREDIcted M) Index	72.48 index Standard Deviation 14.47

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With McAuley Index	46.69 index Standard Deviation 62.28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Belfiore Index	1.52 index Standard Deviation 0.1940

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Cederholm Index	153.25 index Standard Deviation 38.93

PRIMARY outcome

Timeframe: 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)).

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Avignon Index	271.11 index Standard Deviation 115.37

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Matsuda Index	8.15 index Standard Deviation 3.20

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Gutt Index	79.99 index Standard Deviation 16.50

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Stumvoll Index	0.1339 index Standard Deviation 0.0242

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) Index	1.61 index Standard Deviation 0.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With ISI (Insulin Sensitivity Index) Index	18.61 index Standard Deviation 8.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Raynaud Index	6.05 index Standard Deviation 2.59

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With QUICKI (The Quantitative Insulin Sensitivity Check Index) Index	0.36 index Standard Deviation 0.03

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With FIRI (Fasting Insulin Resistance Index) Index	26.13 index Standard Deviation 12.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With Bennett Index	0.64 index Standard Deviation 0.15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Individuals n=25 Participants 3-hour oral glucose tolerance test (OGTT) with 75 grams of glucose load in a single time
Insulin Sensitivity With TyG (Triglycerides and Glucose Index) Index	1.88 index Standard Deviation 0.08

Adverse Events

Healthy Individuals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Manuel González Ortiz

Institute of Experimental andl Clinical Therapeutics

Phone: +52-33-10-58-52-00

Email: uiec@prodigy.net.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place