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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010370
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

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) in healthy patients.

Condition or disease Intervention/treatment
Healthy Lifestyle Diagnostic Test: Oral glucose tolerance test (OGTT)

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, Stumvoll and Gutt 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 sensitivity of fasting insulin with the PREDIcted M (PREDIM) technique, the Pearson or Spearman correlation will be used according to the distribution.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Other
Official Title: Correlation of Several Formulas to Evaluate Sensitivity to Insulin in Fasting With the Predicted M Index (PREDIM) in Healthy Individuals
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin


Intervention Details:
  • Diagnostic Test: Oral glucose tolerance test (OGTT)
    The patient will be cited at 8:00 AM with a minimum of 8 hours of fasting. The weight, height, waist circumference and blood pressure will be taken. Afterwards, a catheter will be placed for the venous blood sample and the biochemical determination of fasting glucose, total cholesterol, HDL, LDL, VLDL, triglycerides and assessment of A1C will be carried out. You will be tested for oral glucose tolerance and insulin sensitivity, for which you will be given a 75-g dose of glucose in water by orally. After the ingestion of the glucose solution, the venous blood sample will be at times 0, 30, 60, 90, 120, 150 and 180 minutes.


Primary Outcome Measures :
  1. Insulin sensitivity with McAuley index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the McAuley index and determine its correlation with the PREDIM index

  2. Insulin sensitivity with Belfiore index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Belfiore index and determine its correlation with the PREDIM index

  3. Insulin sensitivity with Cederholm index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Cederholm index and determine its correlation with the PREDIM index

  4. Insulin sensitivity with Avignon index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Avignon index and determine its correlation with the PREDIM index

  5. Insulin sensitivity with Matsuda index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Matsuda index and determine its correlation with the PREDIM index

  6. Insulin sensitivity with Gutt index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Gutt index and determine its correlation with the PREDIM index

  7. Insulin sensitivity with Stumvoll index [ Time Frame: Baseline ]
    After the oral glucose tolerance test, insulin sensitivity will be calculated with the Stumvoll index and determine its correlation with the PREDIM index


Secondary Outcome Measures :
  1. Changes in fasting glucose levels [ Time Frame: Baseline ]
    The fasting glucose levels will be evaluated at baseline with enzymatic/colorimetric techniques

  2. Changes in postprandial glucose levels [ Time Frame: Baseline ]
    Postprandial glucose will be evaluated at baseline with a oral glucose tolerance test with enzymatic / colorimetric techniques

  3. Total Cholesterol levels [ Time Frame: Baseline ]
    Total cholesterol levels will be evaluated at baseline by enzymatic/colorimetric techniques

  4. Triglycerides levels [ Time Frame: Baseline ]
    Triglycerides levels will be evaluated at baseline by enzymatic/colorimetric techniques

  5. Creatinine levels [ Time Frame: Baseline ]
    Creatinine levels will be evaluated at baseline by enzymatic/colorimetric techniques

  6. Uric acid levels [ Time Frame: Baseline ]
    Uric acid levels will be evaluated at baseline by enzymatic/colorimetric techniques

  7. Body Mass Index [ Time Frame: Baseline ]
    Body Mas Index will be calculated at baseline with the Quetelet index formula

  8. Waist Circumference [ Time Frame: Baseline ]
    Waist circumference will be calculated at baseline with a flexible tape

  9. Body Weight [ Time Frame: Baseline ]
    The body weight will be measured at baseline with a bioimpedance balance

  10. Blood pressure [ Time Frame: Baseline ]
    Blood pressure will be measured at baseline with a digital sphygmomanometer



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010370


Locations
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Mexico
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Manuel Gonzalez Ortiz, PhD Intstituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara.
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Responsible Party: Manuel González Ortiz, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT04010370    
Other Study ID Numbers: PREDIM-sensitivity to insulin
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel González Ortiz, University of Guadalajara:
Insulin sensitivity
PREDIM
Correlation
Healthy individuals
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases