Healthy LifestyleNCT04010370
Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index
An observational study of Healthy Lifestyle, run by University of Guadalajara at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients of both sexes who are not sedentary or who participate in heavy physical activities and residents of the metropolitan area of Guadalajara.
Who may be able to join
- 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
Who cannot join
- Blood pressure >120/80 mmHg
- Glucose >100 mg/dL
- Postprandial glucose >140 mg/dL
- Cholesterol >200 mg/dL
- Triglycerides >150 mg/dL
- Smoking
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals
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.
Read the 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.
- Conditions
- Healthy Lifestyle
- Keywords
- Insulin sensitivity, PREDIM, Correlation, Healthy individuals
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Feb 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- Manuel Gonzalez Ortiz, PhD, Principal investigator, Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010370
- Sponsor's protocol ID
- PREDIM-insulin sensitivity
- Status last verified
- Nov 2020
- First submitted
- 3 Jul 2019
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04010370
- Acronym / sponsor ID
- PREDIM-insulin sensitivity
- Conditions
- Healthy Lifestyle
- Keywords
- Insulin sensitivity, PREDIM, Correlation, Healthy individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients of both sexes who are not sedentary or who participate in heavy physical activities and residents of the metropolitan area of Guadalajara.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Blood pressure >120/80 mmHg
- Glucose >100 mg/dL
- Postprandial glucose >140 mg/dL
- Cholesterol >200 mg/dL
- Triglycerides >150 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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)).
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Gonzalez Ortiz, PhD principal investigator
Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Lifestyle, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity With PREDIM (PREDIcted M) Index (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.