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临床试验/NCT04010370
NCT04010370已完成不适用

Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index (PREDIM) in Healthy Individuals

University of Guadalajara1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Insulin Sensitivity With Avignon Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Blood pressure >120/80 mmHg
  • Glucose >100 mg/dL
  • Postprandial glucose >140 mg/dL
  • Cholesterol >200 mg/dL
  • Triglycerides >150 mg/dL
  • 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

结局指标

主要结局

Insulin Sensitivity With Avignon Index

时间窗: 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 Gutt Index

时间窗: 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

时间窗: 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

时间窗: 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 Raynaud Index

时间窗: 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 ISI (Insulin Sensitivity Index) Index

时间窗: 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 QUICKI (The Quantitative Insulin Sensitivity Check Index) Index

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Insulin Sensitivity With PREDIM (PREDIcted M) Index

时间窗: 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 Cederholm Index

时间窗: 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 Matsuda Index

时间窗: 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 McAuley Index

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel González Ortiz

Researcher Professor

University of Guadalajara

研究点 (1)

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