RU2730949C1 - Method for rapid assessment of risk of type 2 diabetes mellitus or pre-diabetes in individuals of the russian population - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to endocrinology and diabetology. Following parameters are determined in the Russian population: patient's age, intake of preparations for correction of high blood cholesterol, diagnosis of DM type 2 in blood relatives, presence of arterial hypertension, regular physical activity, consumption of preserved and/or smoked and/or excessively salty products; measurement of body weight and growth of patient, based on which is calculated value of body weight index (BWI), determination of sugar level in capillary/venous blood, measurement of waist and hip circumference, determination of waist circumference to hip circumference, measurement of systolic AP. Points are assigned to the obtained values and summed up. And if the value is less than 7 points, absence of impaired glucose tolerance is determined. At less than 11 points, but more than or equal to 7 points, high risk of pre-diabetes is determined. When obtaining "1 and more points" – high risk of presence of DM type 2 is determined.

EFFECT: method enables higher accuracy of diagnosing the disease, reducing an unfavorable prognosis of developing complications of diabetes, as well as detecting a risk group of patients without missing boundary conditions.

1 cl, 2 tbl, 1 dwg, 3 ex

Description

The technical field to which the invention relates

The invention relates to medicine, namely to endocrinology and diabetology, and can be used to assess the risk of prediabetes (PD), type 2 diabetes mellitus (DM).

State of the art

Diabetes mellitus (DM) is a group of metabolic (metabolic) diseases characterized by chronic hyperglycemia, which is the result of impaired insulin secretion, the action of insulin, or both. Chronic hyperglycemia in diabetes is associated with damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.

In the Russian Federation, as in all countries of the world, there is a significant increase in the prevalence of diabetes. According to the federal register of diabetes in the Russian Federation, at the end of 2016, 4.35 million people (3.0% of the population) were registered in the dispensary, of which 92% (4 million) - type 2 diabetes, 6% (255 thousand .) - type 1 diabetes and 2% (75 thousand) - other types of diabetes. The results of a large-scale Russian epidemiological study confirm that only 50% of cases of type 2 diabetes are diagnosed. Thus, the real number of patients with diabetes in the Russian Federation is at least 8-9 million people (about 6% of the population), which poses an extreme threat to the long-term perspective, since a significant part of patients remain undiagnosed, and, therefore, do not receive treatment and have high risk of developing vascular complications.

In the Russian Federation, various screening programs for type 2 diabetes were repeatedly carried out, but they were more of a regional nature. This further emphasizes the need to develop methods for assessing the risk of prediabetes and type 2 diabetes for early diagnosis.

From the prior art, methods are known for assessing the risks of the presence or development of type 2 diabetes, based on a set of various diagnostic indicators, in combination with indicators, incl. regarding adherence to a healthy diet.

In particular, from the publication "Comparative characteristics of the risk scales of type 2 diabetes mellitus" authors Mustafina S.V., Simonova G.I., Rymar O.D. (Journal of Epidemiology. Diabetes mellitus, 2014 (3), pp. 17-22) presents a comparative analysis of various methods of determining the risk of type 2 diabetes mellitus used for Finnish, Australian, Indian, Danish, German, American, Canadian populations, based on the use of various combinations of indicators, including age, gender, BMI, waist circumference (WC), the presence of T2DM in relatives, assessment of physical activity, determination of the presence of arterial hypertension (AH) or regular use of antihypertensive drugs, and incidental detection of hyperglycemia. In a number of scales, the consumption of vegetables / fruits / berries has a significant place, while the German scale also takes into account the consumption of red meat, coffee, alcohol and whole grain bread. In addition, some methods take into account the level of TG, HDL, and fasting blood glucose when assessing the risk of having type 2 diabetes.

However, this method does not provide the accuracy and reliability of the results for the Russian population, and also does not differentiate the risk of a patient with prediabetes and type 2 diabetes. In this publication, the dependence of the set of estimated parameters on the national / country population is noted.

The closest to the claimed is a method for assessing the risk of having type 2 diabetes ("Validation of the Finnish risk scale" FINDRISC "on the Caucasian population of Siberia", authors: Mustafina S.V., Rymar O.D., Sazonova O. V., Shcherbakova L. V., Voevoda M.I., Russia, DOI: 10.1'4341 / DM200418-10; Recommendations: Prevention of chronic non-communicable diseases. Moscow; 2013.40 p.), Based on the use of the Finnish scale "FINDRISC", recommended for use in Russia, containing the following parameters: age, BMI, waist circumference (WC), frequency of consumption of vegetables and fruits, regularity of physical activity, regularity of treatment of arterial hypertension (AH), accidental detection of hyperglycemia, diabetes in a family history.

However, this method also does not provide the required accuracy and reliability of the results for the Russian population, and also does not differentiate the risk of a patient with prediabetes and type 2 diabetes.

A technical problem is the development of a personalized approach to predicting the patient's condition ("norm", "pre-diabetes", "diabetes") in the Russian population.

Disclosure of invention

The technical result of the invention is the rapid identification of patients of the Russian population with a risk of "prediabetes" or type 2 diabetes.

The technical result is achieved through the use of a method for rapid assessment of the risk of diabetes mellitus (DM) type 2 or prediabetes (PD) in individuals of the Russian population, including determination of the patient's age, the fact of taking medications to correct high blood cholesterol, the presence of a diagnosis of type 2 diabetes in blood relatives , the presence of arterial hypertension, regular exercise, consumption of canned and / or smoked and / or excessively salty foods; measuring the patient's body weight and height, on the basis of which the value of the body mass index (BMI) is calculated, determining the level of sugar in capillary / venous blood, measuring the circumference of the waist and hips, determining the ratio of the waist circumference to the circumference of the hips, measuring the systolic blood pressure;

if the patient's age is less than 49 years for women, less than 46 years for men, 0 points are assigned, if the age is 49-51 years for women, 46-58 years for men - 4.5 points, if 52 years and above for women, 59 years old and above; for men - 6.5 points;

if BMI is less than 26, assign "0 points", if 26-30 - "3.5 points", 31 and more - "6.5 points";

if an elevated level of sugar in capillary / venous blood is detected at least once on an empty stomach, "7.5 points" is assigned, no - "0 points";

if the waist circumference is less than 100 cm for women, less than 112 cm for men is assigned "0 points", more than or equal to 100 cm for women and more than or equal to 112 cm for men - "2.5 points";

if the ratio of waist circumference to hip circumference is more or equal to 0.85 for women and more than or equal to 0.92 for men, "2 points" are assigned, less than the indicated values - "0 points";

in the presence of arterial hypertension, assign "0.5 points", in the absence - "0 points";

if the usual systolic blood pressure is higher or equal to 132 mm Hg. assign "3.5 points", less than the specified value - "0 points";

if there is a fact of taking medications to correct high blood cholesterol, "1.5 points" are assigned, the absence - "0 points";

in the case of a diagnosis of type 2 diabetes mellitus in blood relatives, "2.5 points" are assigned, in the absence - "0 points";

in case of physical activity at least 3 times a week for at least 30 minutes, assign "minus 1.5 points", in the absence - "0 points";

if the consumption of canned and / or smoked and / or excessively salty foods is 4 times a week or more, "1.5 points" is assigned, less than the specified value - "0 points";

the points obtained are summed up, and in the case of obtaining a value of "less than 7 points" determine the absence of impaired glucose tolerance; "Less than 11 points, but more than or equal to 7 points" - determine the high risk of having PD, when receiving "11 or more points" - determine the high risk of having type 2 diabetes.

The inventive method is based on extensive epidemiological data of the Russian population. Some parameters are present in the known methods of foreign researchers, however, the listed set of signs is unique, allowing the detection of these diseases, reducing the unfavorable prognosis of the development of diabetes complications. In addition, the quantitative values of diagnostically significant indicators, as shown by the results of our studies, are characteristic of the Russian population. It is the set of indicators developed by us (available in terms of research, obtaining) that allows us to identify a risk group of patients without missing borderline states.

Brief Description of Drawings

The invention is illustrated by a model diagram (Fig. 1), which was used to determine the original set of diagnostic indicators and their gradations.

Implementation of the invention

The claimed invention is based on the definition of indicators presented in Table 1.

The received points are summed up and in case of receiving the value:

less than 7 points determine the absence of impaired glucose tolerance;

less than 11 points, but more than or equal to 7 points - determine a high risk of having prediabetes,

if you receive 11 or more points, they determine a high risk of having type 2 diabetes.

To implement the proposed method, all the indicators listed in Table 1 are determined, after which the scores are summed up, as a result of which the final numerical value makes it possible to assess the need for screening for diabetes or prediabetes. The sensitivity and specificity of the method based on the use of a set of diagnostic indicators were 83.9% and 76.8%, respectively, for the logistic regression model for diabetes.

The baseline data was a patient database obtained in the course of large epidemiological studies. Before all edits, the share of respondents with HbA1> = 6.5 was 4.4% (1174 out of 26620), the share of respondents with 5.7 <= HbA1 <6.5 was 20% (5324 out of 26620). Taking into account the previously diagnosed cases of diabetes: the share of respondents with diabetes was 5.5% (1454 out of 20620), the share of respondents with PD was 19.3% (5125 out of 26620).

To simulate the likelihood of DM and PD in the MATLAB R2014a environment, logistic regression was trained separately for the base with diabetes and for the base with prediabetes. The values obtained from the analysis of the graphs of the distribution of the shares of respondents with DM and PD were used as the initial boundaries. Based on the results of the studies, the best model was obtained, which included the parameters presented in Table 1.

Cross-validation was used to check the adequacy of the model. All observations were divided into 10 independent parts, training was carried out in 9 parts, and results were evaluated in 1 part. Each of the 10 parts was used as a test subset, so training was performed 10 times on different training subsets. Variable coefficients varied insignificantly on different training subsets.

Different sets of parameters were tested, for each set the area under the ROC curve was estimated. After determining the sets of parameters with the maximum area under the ROC curve, a sensitivity analysis was performed, as a result of which optimal boundaries were found for grouping patients by age, BMI, waist size, waist-to-hip ratio, pressure, income, and dietary habits. As a result of the work carried out, the optimal set of parameters for the logistic regression was formed for PD and SD. Table 2 below shows the calculation results, as well as the values of the coefficients.

PD - prediabetes; DM - diabetes mellitus; PPV - positive predictive value (predictive value of a positive result, the probability of having a disease with a positive (pathological) test result); NPV - negative predictive value (predictive value of a negative result, the likelihood of no disease with a negative (normal) test result).

In total, using the proposed method, 649 cases of diabetes out of 774 and 3823 cases of PD out of 5092 were "caught". This method is unique. When compared with similar scales, for example FINDRISK, a smaller set of risk factors is used, and the results obtained only allow us to determine the possible risks, but are not confirmed by the available laboratory tests. The data we obtained were collected on the territory of 8 federal districts (63 regions) of the Russian Federation, while similar data from the FINDRISC questionnaire were obtained by questioning the adult population of Novosibirsk. According to the data obtained, not all the risk factors included in the FINDRISC scale are widespread in people with new-onset type 2 diabetes, and the incidence of new-onset diabetes in the very high-risk group (group 5) was lower than predicted in Finland: 22.6 % versus 50%. (Mustafina S.V., Rymar O.D., Sazonova O.V., et al. Validation of the Finnish risk scale "FINDRISC" on the Caucasian population of Siberia // Diabetes mellitus. - 2016. - V. 19. - No. 2. - S. 113-118.doi: 10.14341 / DM200418-10)

Thus, the proposed method for assessing the risks of developing type 2 diabetes will make it possible to identify diabetes or prediabetes in the early stages. The use of the proposed technique does not require any special skills and only requires filling in the specified table. The proposed method is effective and can be used in all patients.

Examples of implementation of the invention

Example 1:

• Man, 64 years old,

• BMI = 37,

• waist circumference = 122 cm,

• waist-to-hip ratio = 1.09,

• systolic pressure = 150,

• a sister was diagnosed with type 2 diabetes,

• have previously detected blood sugar,

• the patient does not play sports,

• previously diagnosed with hypertension,

• does not take drugs for the treatment of high and high cholesterol levels.

• Eats canned foods more than 4 times a week

The sum of points, determined according to Table 1, was 33 points. This value exceeds the threshold for diabetes of 11 points, therefore, the patient has a high risk of having a diagnosis of type 2 diabetes.

The patient was advised to undergo blood tests for glycated hemoglobin and fasting blood glucose.

During the examination, the following results were obtained: fasting plasma glucose -10.2 mmol / l, glycated hemoglobin - 8.2%. Based on the data obtained, the diagnosis was made of type 2 diabetes mellitus for the first time. The endocrinologist at the place of residence prescribed treatment.

Example 2:

• Woman, 66 years old,

• BMI = 29,

• waist circumference = 99 cm,

• waist-to-hip ratio = 0.83,

• systolic pressure = 120,

• no family member has been diagnosed with type 2 diabetes,

• previously, high blood sugar was not detected,

• physical activity is sufficient,

• have not previously established a diagnosis of hypertension,

• is taking medications to treat high and high cholesterol levels.

• Eats excessively salty foods more than 4 times a week

The sum of points for all items in Table 1 was 10 points. This value does not exceed the threshold for diabetes of 11 points, however, it exceeds the threshold for PD of 7 points.

Thus, the patient was recommended to undergo an examination by passing a blood test for glycated hemoglobin and fasting plasma glucose.

The following data were obtained: fasting plasma glucose - 6.7 mmol / l, glycated hemoglobin - 6.6%. These values are consistent with prediabetes. The endocrinologist at the place of residence recommended an oral glucose tolerance test, on the basis of which the diagnosis was made: impaired glucose tolerance. Nutritional recommendations were given and therapy was prescribed.

Example 3.

• Man, 39 years old,

• BMI = 35,

• waist circumference = 109 cm,

• waist-to-hip ratio = 0.87,

• systolic pressure = 130,

• average monthly income per family member = 15,000,

• no family member has been diagnosed with type 2 diabetes,

• previously, high blood sugar was not detected,

• the patient does not play sports,

• have not previously established a diagnosis of hypertension,

• is not taking drugs to treat high and high cholesterol.

• Does not consume excessively salty foods more than 4 times a week

The sum of points for all items in Table 1 was 6.5 points. This value does not exceed the threshold for diabetes of 11 points and does not exceed the threshold for PD of 7 points, the risk of prediabetes and diabetes mellitus is low. Weight control is recommended. Laboratory blood tests have confirmed this conclusion.

The use of the proposed method does not require any special skills and requires only filling out the specified table 1. The proposed method is effective and can be used in all patients.

Claims (13)

A method for rapid assessment of the risk of type 2 diabetes mellitus (DM) or prediabetes (PD) in people of the Russian population, including determining the patient's age, the fact of taking medications to correct high blood cholesterol, the presence of a type 2 diabetes diagnosis in blood relatives, arterial hypertension, regularity physical activity, consumption of canned and / or smoked and / or excessively salty foods; measuring the patient's body weight and height, on the basis of which the value of the body mass index (BMI) is calculated, determining the level of sugar in capillary / venous blood, measuring the circumference of the waist and hips, determining the ratio of the circumference of the waist to the circumference of the hips, measuring the systolic blood pressure (BP); in case the patient's age is less than 49 years for women, less than 46 years for men, 0 points are assigned, if the age is 49-51 years for women, 46-58 years for men - 4.5 points, if 52 years and above for women, 59 years old and above; for men - 6.5 points; if BMI is less than 26, assign "0 points", if 26-30 - "3.5 points", 31 and more - "6.5 points"; if an elevated level of sugar in capillary / venous blood is detected at least once on an empty stomach, "7.5 points" is assigned, no - "0 points"; if the waist circumference is less than 100 cm for women, less than 112 cm for men is assigned "0 points", more than or equal to 100 cm for women and more than or equal to 112 cm for men - "2.5 points"; if the ratio of waist circumference to hip circumference is more or equal to 0.85 for women and more than or equal to 0.92 for men, "2 points" are assigned, less than the indicated values - "0 points"; in the presence of arterial hypertension, assign "0.5 points", in the absence - "0 points"; if the usual systolic blood pressure is higher or equal to 132 mm Hg. assign "3.5 points", less than the specified value - "0 points"; if there is a fact of taking medications to correct high blood cholesterol, "1.5 points" are assigned, the absence - "0 points"; in the case of a diagnosis of type 2 diabetes mellitus in blood relatives, "2.5 points" are assigned, in the absence - "0 points"; in case of physical activity at least 3 times a week for at least 30 minutes, assign "minus 1.5 points", in the absence - "0 points"; if the consumption of canned and / or smoked and / or excessively salty products is 4 times a week or more, "1.5 points" is assigned, less than the specified value - "0 points"; the points obtained are summed up, and in the case of obtaining a value of "less than 7 points" determine the absence of impaired glucose tolerance; "Less than 11 points, but more than or equal to 7 points" - determine the high risk of having PD, when receiving "11 or more points" - determine the high risk of having type 2 diabetes.

Images