Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals
Conditions: Healthy Lifestyle
Sponsor: University of Guadalajara

 
 
 
 
 
 
“Correlation of Several Formulas to Evaluate Insulin 
Sensitivity With the Predicted M Index (PREDIM) in 
Healthy Individuals” 
 
NCT 04010370 
 
May 17, 2018 
 
 
 

 
INDEX OF CONTENTS 
 
INDEX OF CONTENTS ........................................................................................................................... 2 
1. INTRODUCTION ............................................................................................................................... 3 
2. MATERIALS AND METHODS ............................................................................................................ 4 
2.1 Study desing .............................................................................................................................. 4 
2.2 Universe of work ....................................................................................................................... 4 
2.3 Sample size ................................................................................................................................ 4 
2.4 Selection criteria ....................................................................................................................... 5 
2.4.1 Inclusion criteria ................................................................................................................. 5 
2.4.2 Exclusion criteria ................................................................................................................ 5 
2.4.3 Elimination criteria ............................................................................................................. 5 
2.5 Variables .................................................................................................................................... 6 
2.5.1 Independent variable ......................................................................................................... 6 
2.5.2 Dependent variables .......................................................................................................... 6 
2.5.3 Intervening variables .......................................................................................................... 6 
2.6 Study groups and administration of the intervention .............................................................. 6 
2.7 Measurement and evaluation procedures ................................................................................ 6 
2.7.1 Clinical determinations....................................................................................................... 6 
2.7.2 Laboratory determinations ................................................................................................ 7 
2.7.3 Calculations ........................................................................................................................ 8 
2.7.4 Description of the study ..................................................................................................... 9 
3. STATISTIC ANALYSIS ...................................................................................................................... 10 
4. FINANCING .................................................................................................................................... 10 
5. BIBLIOGRAPHIC REFERENCES ........................................................................................................ 10 
 
 
 

 
1. INTRODUCTION 
 
The term insulin sensitivity-insensitivity is referred to for the first time in 1936 by 
Himsworth, who took a background from redactions dating back to 100-200 BC. of C. Insulin 
sensitivity is defined as its effectiveness in lowering blood glucose by promoting glucose 
uptake by muscle and adipose tissue cells, increasing hepatic glycogen production, and 
reducing hepatic glucose production. 2,3 Therefore, insulin resistance is a pathophysiological 
phenomenon in which, for a given concentration of this hormone, an adequate reduction 
in blood glucose levels is not achieved, which is results in the event for which the individual 
is able to maintain a normal tolerance to glucose over finite periods and comes intolerance 
carbohydrates and at consecuence, the occurrence of various diseases as diabetes mellitus, 
the arterial hypertension and central obesity.4,5 
Early diagnosis of insulin resistance along with timely intervention can prevent the 
onset of these conditions. He currently has several methods for measuring sensitivity, 
within which the most accurate and precise, considered the "gold standard" is the clamp to 
hyperglucemic-hyperinsulinemic. However, they are expensive and time-consuming and 
personnel-intensive, so they are limited for use in specialized experimental clinical research 
centers and not as a diagnostic means. This has led to the search and development of 
indices that allow to quantify insulin sensitivity/resistance, classified according to the data 
used for the calculation in:7 
1. Indices calculated using fasting plasma concentrations of insulin, glucose and 
triglycerides: HOMA-IR (Homeostatic Evaluation Model), Quantitative verification of 
insulin sensitivity (QUICKI), insulin sensitivity (ISI), Raynaud's, fasting insulin 
resistance (FIRI), Bennett, triglycerides and glucose (TyG). 
2. Indices calculated using plasma insulin and glucose concentrations obtained over 
120 min of a standard (75 g glucose) PTOG: Hyperglycemic-hyperinsulinemic clamp 
(CLAMP), McAuley, Belfiore, Cederholm, Avignon, Stumvoll, Gutt, Matsuda. 
 

 
Recently, an index based on the oral glucose insulin sensitivity index (OGIS) in 
combination with anthropometric variables, called PREDIcted M (PREDIM), has been 
proposed; however, there is no evidence of its validation with respect to the various indices 
for the evaluation of insulin sensitivity, so the objective of this protocol is compare them 
with the afore mentioned indices.8 
 
2. MATERIALS AND METHODS 
 
2.1 Study desing 
An analytical cross-sectional study will be carried out. 
2.2 Universe of work 
Healthy male and female population, 30 to 60 years old, residents of the Guadalajara metropolitan 
zone. 
2.3 Sample size 
The sample size was calculated with the formula for simple correlation in a group 9: 
𝑛= 3 + 𝐾
𝐶2 
 
PREDIcted M (PREDIM) 
 
Insulin sensitivity 
Confidence level 
95 % 
Statistical power 
80 % 
K (Zα + Zβ) 
13.09 
R 
0.6928 
C= 𝟎. 𝟓 𝐥𝐧
𝟏+𝐫
𝟏−𝐫 
0.8517 
N 
20.92 
n with 20 % losses 
25 
 
 

 
2.4 Selection criteria 
 
2.4.1 Inclusion criteria 
• Both genders 
• 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 
2.4.2 Exclusion criteria 
 
• Blood pressure >120/80 mmHg 
• Glucose >100 mg/dL 
• Glucose postprandial >140 mg/dL 
• Cholesterol >200 mg/dL 
• Triglycerides >150 mg/dL 
• Smoking 
• Women with polycystic ovary syndrome 
• History of metabolic, cardiovascular, thyroid, renal, pancreatic and/or arterial 
hypertension disease 
• Use of medications that modify insulin sensitivity (corticosteroids) 
• Previous surgery or infection 
• 
Symptoms of vomiting and/or excessive nausea 
2.4.3 Elimination criteria  
• Nausea and/or vomiting 
• Feeling faint or faint 
• Intolerance to oral anhydrous glucose load 
• Withdrawal of consent under information 
 

 
2.5 Variables 
 
2.5.1 Independent variable 
• PREDIcted M (PREDIM) 
2.5.2 Dependent variables 
 
• Insulin sensitivity 
• McAuley index 
• Belfiore index 
• Cederholm index 
• Avignon index 
• Matsuda index 
• Gutt index 
• Stumvoll index 
• HOMA-IR index 
• ISI index 
• Raynaud index 
• QUICKI index 
• FIRI index 
• Bennett index 
• 
TyG index 
2.5.3 Intervening variables 
 
• Follicular phase of a woman's menstrual cycle. 
2.6 Study groups and administration of the intervention 
• 
25 healthy patients will be tested for oral glucose tolerance test. 
 
2.7 Measurement and evaluation procedures 
 
2.7.1 Clinical determinations 
Age: 
Patients from 30 to 60 years old will be included volunteers who agree to participate 
and sign informed consent, residents of the metropolitan area of Guadalajara. 

 
Gender: 
It will be registered as M (Male ) and F (Female). 
BMI: 
It will be obtained from the division between the weight in kilograms and the height 
in square meters (kg/m2). 
Waist circumference: 
It will be measured with a tape measure of flexible material graduated in 
centimeters (cm), with the subject in a standing position, for which, the tape will be placed 
in a plane parallel to the horizontal and without clothing at the level of the measurement. 
The tape will be placed at the level of the middle zone between the costal border and the 
iliac crests at the end of a normal expiration 
Weight: 
Measurements will be recorded in kilograms (kg) using a stationary TANITA® 
electrical bioimpedance scale. It will be measured with the participant in a standing position 
and wearing light clothing, without footwear and with the bladder evacuated before the 
measurement. 
Blood pressure: 
Measurements will be recorded in millimeters of mercury (mmHg) using the OMRON 
HEM 907 XL digital sphygmomanometer. For this, the subject will be placed in a sedative 
position and after 15 min of rest, a bracelet will be adjusted 3 cm above the fold of the 
elbow of the left arm. 3 intakes and an average blood pressure will be taken. 
 
 
2.7.2 Laboratory determinations  
For serum glucose measurements (fasting and PTOG at 3 h), secretion and sensitivity to 
insulin, total cholesterol, triglycerides, creatinine and uric acid, a catheter will be placed for 
the venous blood sample, the measurements will be made by simple enzymatic-
colorimetric techniques with an automated clinical chemistry analysis equipment XL-
100Erba® brand, which will be routinely calibrated according to the general laboratory log 
and will be operated by a single certified chemist assigned to this study. 

 
2.7.3 Calculations  
Insulin sensitivity:  
it will be calculated with the indices: 
Index 
Formula 
PREDICted M 
(PREDIM) 
𝐴+ 𝐵× 𝑙𝑜𝑔𝑒(𝑂𝐺𝐼𝑆) + 𝐶× 𝑙𝑜𝑔𝑒(𝐼𝑀𝐶) + 𝐷× 𝑙𝑜𝑔𝑒(2ℎ𝐺𝑙𝑢) + 𝑙𝑜𝑔𝑒(𝐼𝑁𝑆𝑓) 
Matsuda 
10000
√(𝐺0𝐼0)(𝐺𝑚𝑒𝑎𝑛𝐼𝑚𝑒𝑎𝑛)
 
McAuley 
𝑒[2.63 −0.28 𝐼𝑛(𝐼0) −0.31 𝐼𝑛 (𝑇𝐺0)] 
Belfiore 
2
𝐼𝑆𝐼𝐵𝑒𝑙𝑓𝑖𝑜𝑟𝑒
= 𝐺𝑠
𝐺𝑁
× 𝐼𝑠
𝐼𝑁
+ 1 
Cederholm 
75000 + (𝐺0 − 𝐺120) x 1.15 x 180 x 0.19 x 𝑏𝑜𝑑𝑦 𝑤𝑒𝑖𝑔ℎ𝑡
120 x 𝐺𝑙𝑢𝑚𝑒𝑎𝑛 x 𝑙𝑜𝑔(𝐼𝑛𝑠𝑚𝑒𝑎𝑛)
 
Avignon 
𝑆𝑖𝑏=
108
𝐼0 (𝜇𝑈
𝐼) × 𝐺0 (𝑚𝑚𝑜𝑙
𝑙
) × 𝑉𝐷
 
𝑆𝑖2ℎ=
108
𝐼120(𝜇𝑈/𝐼) × 𝐺120(𝑚𝑚𝑜𝑙/𝑙) × 𝑉𝐷 
𝑆𝑖𝑀=
(0.137 x 𝑆𝑖𝑏) + 𝑆𝑖2ℎ
2
 
Stumvoll 
0.156 −0.0000459 x 𝐼120[𝑝𝑚𝑜𝑙/𝑙] −0.000321 x 𝐼0[𝑝𝑚𝑜𝑙/𝑙]
−0.00541 x 𝐺120(𝑚𝑚𝑜𝑙/𝑙)] 
Gutt 
75000 + (𝐺0 −𝐺120)(𝑚𝑔/𝑑𝑙) × 0.10 × 𝑃𝐶
120 × 𝐺𝑚𝑒𝑎𝑛(𝑚𝑚𝑜𝑙/𝑙) × log [𝐼𝑚𝑒𝑎𝑛](𝜇𝑈/𝑙) 
HOMA-IR 
(𝐹𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛)(𝜇𝐼𝑈𝑚𝑙
⁄
) x (𝐹𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒)(𝑚𝑚𝑜𝑙𝑙
⁄ )
22.5
 
ISI 
10000
(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛) x (𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒) 
Raynaud 
40
𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛 
QUICKI 
1
𝑙𝑜𝑔(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛)(𝜇𝐼𝑈𝑚𝑙
⁄
) +  𝑙𝑜𝑔(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒)(𝑚𝑔𝑑𝑙
⁄
) 

 
FIRI 
(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛) x (𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒)
25
 
Bennett  
1
𝑙𝑜𝑔(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑖𝑛𝑠𝑢𝑙𝑖𝑛) x 𝑙𝑜𝑔(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒) 
TyG 
𝐿𝑛(𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑡𝑟𝑖𝑔𝑙𝑦𝑐𝑒𝑟𝑖𝑑𝑒𝑠)(𝑚𝑔𝑑𝑙
⁄
) x (𝑓𝑎𝑠𝑡𝑖𝑛𝑔 𝑔𝑙𝑢𝑐𝑜𝑠𝑒)(𝑚𝑔𝑑𝑙
⁄
)
2
 
 
 
2.7.4 Description of the study 
Scrutiny visit 
All patients will be scheduled at 8:00 AM with a minimum of 8 hours of fasting. The 
candidate volunteers will be provided with the information regarding the study, and the 
benefits to their health, the possible adverse effects, the objectives and the methodology 
that will be implemented will be indicated, with the purpose of submitting to the patient's 
consideration the signature of the consent under information to accept to participate. Once 
signed, the screening tests will be carried out according to the inclusion criteria, as well as 
capturing the clinical history and the complete physical examination. A venous blood 
sample will be taken for evaluation of clinical biochemical selection criteria, which include 
serum concentrations of: fasting glucose, lipid profile, creatinine and uric acid. 
All participants who satisfactorily meet the selection criteria will be included in the 
intervention phase.. 
Baseline visit (Day 1) 
The patient will be scheduled at 8:00 AM with a minimum of 8 hours of fasting. 
Weight, height, waist circumference and blood pressure will be taken. Subsequently, a 
catheter will be placed for the venous blood sample; an oral glucose tolerance and insulin 
sensitivity test will be performed, for which a 75 g dose of glucose dissolved in water will be 
administered orally. After the ingestion of the glucose solution, the venous blood will be 
taken at times 0, 30, 60, 90, 120, 150 and 180 minutes. 

 
 
3. STATISTIC ANALYSIS 
 
Statistical analyses will be performed using SPSS statistical software (version 25). 
Values will be presented as measures of central tendency and dispersion, mean ± standard 
deviation. Nominal variables in numbers and percentages. The Kolmogorov-Smirnov test 
will be performed to determine if the variables follow a normal distribution. Spearman 
correlation coefficients will be used to analyze the univariate relationship between index 
Predicted M (PREDIM) technique with various indices (McAuley, Belfiore, Cederholm, 
Avignon, Matsuda, Gutt, Stumvoll, HOMA-IR, ISI, Raynaud, QUICKI, FIRI, Bennett and TyG). 
A P value less than 0.05 will be considered significant. 
 
4. FINANCING 
The financing will be by own resources of the University of Guadalajara. 
 
 
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