FIELD OF THE INVENTION
[001] The present invention generally relates to endocrinology, and obesity.
[002] More particularly, the present invention relates to the case control method for Diabetes mellitus as a risk factor for ischemic stroke.
BACKGROUND FOR THE INVENTION:
[003] By reference to UA application no. UA16209U by Univ Oo Bohomolets Nat Medical dated 2006-03-28, titled” Method for treating ischemic stroke in patients with diabetes mellitus” discloses method for treating the ischemic stroke in the patients with diabetes mellitus comprises the use of Berlition.
[004] By reference to RU application no. RU2731911C1 by Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation dated 2019-12-23, titled” Method for predicting the outcome of an acute period of ischemic stroke in type 2 diabetes mellitus patients” discloses medicine, namely neurology, and can be used to predict the outcome of an acute period of ischemic stroke in patients suffering type 2 diabetes mellitus. Method for predicting the outcome of an acute period of ischemic stroke (IS) in patients with type 2 diabetes mellitus involves determining in the first three days a disease of glycolised HbA1c hemoglobin and the HbA1c level of more than 6.0 % shows the favorable outcome of the IS in the acute period, the HbA1c level of 6.0 % and the less – lethal outcome of IS in the acute period.
[005] By reference to RU application no. RU2009112232A by State Educational Institution of Higher Professional Education "Ivanovo State Medical Academy, State Educational Institution of Higher Professional Education "Ivanovo State Medical Academy of the Federal Agency for Health and Social Development” dated 2009-04-02, titled” METHOD FOR PREDICTING THE OUTCOME OF CARDIOCEREBRAL PATHOLOGY IN PATIENTS WITH SUGAR DIABETES” discloses a method for predicting the outcome of cardiocerebral pathology in patients with diabetes mellitus (DM), including the allocation of clinical and morphological signs and their four-point assessment, characterized in that the patient distinguishes the following prognostic signs: gender, age, ability to work, seasonality, previous acute cerebrovascular accident (ONMC) ), a variant of the development of stroke, the duration of the prehospital period, the severity of the stroke, the state of consciousness, the duration of the coma, the duration (DM), the form of chronic coronary heart disease (CHD), the duration of CHD, the degree of circulatory failure, echocardiography data, the severity of diabetes, the status of compensation for diabetes, visceral complications of diabetes, pulmonary complications, hypertension / symptomatic arterial hypergenia, blood rheology, the extent and localization of cerebral infarction, the state of the lumen of intracranial arteries, complicated forms of atherosclerosis, prognostic signs are scored according to the "Map for predicting the outcome of ischemic stroke in a patient patients with chronic coronary heart disease and diabetes mellitus ”, the obtained points are summarized and with a total of 61 points or more they predict a high probability of a lethal outcome of ischemic stroke.
[006] By reference to RU application no. RU2731177C1 by Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation dated 2019-12-23, titled” Method for predicting the outcome of an acute period of ischemic stroke in patients not suffering type 2 diabetes mellitus” discloses medicine, namely neurology, and can be used for prediction of the clinical outcome in the acute period of ischemic stroke in the patients not suffering type 2 diabetes mellitus. Method for predicting the outcome of an acute period of ischemic stroke in patients not suffering type 2 diabetes mellitus, comprising determining on the first day of the disease in the patient's venous blood the content of two indicators and ratio thereof, wherein the indices are determined by concentration of C-peptide in nmol/l and immunoreactive insulin (IRI) in mcME/ml, and if the C-peptide/IRI concentration ratio is less than 0.130, a favorable outcome is predicted, with ratio of 0.130 and more – a lethal outcome.
[007] By reference to RU application no. RU2739118C1 by Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation dated 2019-12-23, titled” Method for predicting the course of an acute period of ischemic stroke in type 2 diabetes mellitus patients” discloses medicine; neurology. SUBSTANCE: invention can be used for prediction of clinical course of ischemic stroke (IS) in acute type 2 diabetes mellitus. Method for prediction of clinical course of acute ischemic stroke in patients with type 2 diabetes mellitus involves determining in the first three days of venous blood disease content, wherein the indicator is the C-peptide concentration, and if value is 1.33 nmol/l and less, the non-severe acute clinical course in the patients suffering type 2 diabetes mellitus is predicted, if its value is more than 1.33 nmol/l—severe course of acute disease in patients with type 2 diabetes mellitus.
[008] By reference to RU application no. RU2764954C1 by Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of the Russian Federation dated 2021-10-11, titled” Method for predicting risk of death in patients with type 2 diabetes mellitus in combination with covid-19” discloses medicine, namely endocrinology, intensive care, and can be used in predicting the risk of death in patients with type 2 diabetes mellitus (DM2) in combination with COVID-19. To do this, in a patient with type 2 diabetes with COVID-19, the levels of urea, creatinine, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), C-reactive protein (CRP), international normalized ratio (INR), D-dimer, lactate dehydrogenase (LDH), leukocytes, erythrocyte sedimentation rate (ESR) are determined in the blood. With a combination of factors such as urea levels over 10.15 mmol/L, creatinine levels over 105.4 mmol/L, ALAT above 20.8 U/L, ASAT above 36.7 U/L, CRP above 98.2 mg/L, leukocytes over 10.7×109/L, ESR above 33.6 mm/h, INR above 1.02, D-dimer above 295.15 u/L, LDH above 516.09 U/L, lethal the outcome in patients with type 2 diabetes from COVID-19.EFFECT: method provides prediction of the risk of death in patients with type 2 diabetes mellitus in combination with COVID-19 by determining certain significant diagnostic criteria.
[009] By reference to CA application no. CA3056663A1 by Eli Lilly and Co dated 2019-09-25, titled” Use of dulaglutide in reducing risk of cardiovascular events in patients with type 2 diabetes mellitus” discloses methods for reducing the risk of major adverse cardiovascular events in type 2 diabetes mellitus (T2DM) patients with multiple cardiovascular risk factors without established cardiovascular disease or with established cardiovascular disease comprising administering the glucagon like peptide-1 (GLP-1) receptor agonist dulaglutide.
[010] By reference to US application no. US20120277147A1 by Sanofi Aventis Deutschland GmbH dated 2012-03-28, titled” Prevention of hypoglycaemia in diabetes mellitus type 2 patients” discloses method for the prevention of hypoglycaemia in diabetes mellitus type 2 comprising administering (a) desPro36Exendin-4(1-39)-Lys6-NH2 or/and a pharmaceutically acceptable salt thereof, and (b) a sulfonylurea or/and a pharmaceutically acceptable salt thereof, to a subject in need thereof.
[011] However, none of the above-discussed inventions provides such a case control method for diabetes mellitus as a risk factor for ischemic stroke. The method comprises a plurality of steps.
OBJECTS OF THE INVENTION:
[012] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[013] The main object of the present invention is to provide a case control method for Diabetes mellitus as a risk factor for ischemic stroke.
[014] Another object of the invention is to provide a demographic distribution of the cases and controls.
[015] Another object of the invention is to provide quantitative parameters such as age were expressed as mean and standard deviation.
[016] Another object of the invention is to ascertain association of risk factor with stroke, the analysis was conducted through calculation of odd ratio (OR) and confidence internal (CI) by using SPSS 22.0 program.
[017] Another object of the invention is to provide a evaluating risk factor, significant p-values were taken as less than 0.05.
[018] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
[019] According to one aspect of our invention, case control method for Diabetes mellitus as a risk factor for ischemic stroke comprising the steps : a) The sample size was calculated for matched case control (1:1 ratio) by nMaster software; wherein a minimum number of required pairs of case and control came out to be 189; b) Controls (1:1) were selected from the same hospital but admitted for conditions other than ischemic stroke; c) Inclusion/exclusion criteria: patients diagnosed with first ischemic stroke or transient ischemic attack (TIA) within seven days of onset, ready to give written consent and age group 20 years and above were included; d) Data collection: a predesigned and pretested modified questionnaire for WHO stepwise approach to chronic disease risk factor surveillance and WHO stepwise approach to stroke surveillance were used for data collection; e) Analysis: quantitative parameters such as age were expressed as mean and standard deviation; To ascertain association of risk factor with stroke, the analysis was conducted through calculation of odd ratio (OR) and confidence internal (CI) by using SPSS 22.0 program; f) Among modifiable risk factor like diabetes mellitus was found to be a significant risk factor in patients with Ischemic stroke; wherein therefore it is very essential to estimate the risk factors for better understanding the pathophysiology, to make proper prevention strategies to decrease the burden of stroke in the population.
[020] In another aspect of the invention, socio-demographic characteristics of the cases and controls. 128 (67.7%) were male and 61(32.3%) were female in both groups.
[021] In another aspect of the invention, all subjects were distributed in a range of 20 years age groups: 20-40, 40-60, 60-80 and >80 in both case and control.

BRIEF DESCRIPTION OF DRAWINGS:
[022] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[023] Figure 1: illustrates a case control method for Diabetes mellitus as a risk factor for ischemic stroke, as per an embodiment of the present invention.
[024] The referral numerals in the figures refer to: 2, 3, 4, 5, 6, 7, 8, 9 - case control method steps.
BRIEF DESCRIPTION OF INVENTION:
[025] The present invention will now be described hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. While the following description details the preferred embodiments of the present invention is not limited in its application to the details of construction and arrangement of the parts illustrated in the accompanying drawings. With reference to the figures, the enclosed description and drawings are merely illustrative of preferred embodiments and represent several different ways of configuring the present invention. Although specific components, materials, configurations and uses of the present invention are illustrated and set forth in this disclosure, it should be understood that a number of variations to the components and to the configuration of those components described herein and in the accompanying figures can be made without changing the scope and function of the invention set forth herein.
[026] The present invention proposes a case control method for Diabetes mellitus as a risk factor for ischemic stroke comprising the steps : a) The sample size was calculated for matched case control (1:1 ratio) by nMaster software; wherein a minimum number of required pairs of case and control came out to be 189; b) Controls (1:1) were selected from the same hospital but admitted for conditions other than ischemic stroke; c) Inclusion/exclusion criteria: patients diagnosed with first ischemic stroke or transient ischemic attack (TIA) within seven days of onset, ready to give written consent and age group 20 years and above were included; d) Data collection: a predesigned and pretested modified questionnaire for WHO stepwise approach to chronic disease risk factor surveillance and WHO stepwise approach to stroke surveillance were used for data collection; e) Analysis: quantitative parameters such as age were expressed as mean and standard deviation; To ascertain association of risk factor with stroke, the analysis was conducted through calculation of odd ratio (OR) and confidence internal (CI) by using SPSS 22.0 program; f) Among modifiable risk factor like diabetes mellitus was found to be a significant risk factor in patients with Ischemic stroke; wherein therefore it is very essential to estimate the risk factors for better understanding the pathophysiology, to make proper prevention strategies to decrease the burden of stroke in the population.
[027] The present invention as illustrated in Figure 1 provides another embodiment of the invention which includes a case control method for Diabetes mellitus as a risk factor for ischemic stroke.

[028] In another embodiment, Table 1 depicts socio-demographic characteristics of the cases and controls. 128 (67.7%) were male and 61 (32.3%) were female in both groups .All subjects were distributed in a range of 20 years age groups: 20-40, 40- 60, 60-80 and >80 in both case and control. Among cases there were equal no of subjects in the age group of 40-60 and 60-80 year (43.4% in both) whereas among controls maximum respondents were in the age group of 40-60 years (47.1%). Least participants were found in >80 years age group among both cases and controls. Mean age of case and control were 58.86±13.03 and 58.21±12.67.

[029] In another embodiment, sample size: it was assumed that 50% is the proportion of exposed controls and 5% is the level of significance with power 90% in order to detect a threefold increased risk.
[030] In another embodiment, the sample size was calculated for matched case control (1:1 ratio) by nMaster software. A minimum number of required pairs of case and control came out to be 189.
[031] In another embodiment, control: the controls (1:1) were selected from the same hospital but admitted for conditions other than ischemic stroke. Age (±5 years) and sex of controls were matched to cases.
[032] In another embodiment, inclusion/exclusion criteria: patients diagnosed with first Ischemic stroke or transient ischemic attack (TIA) within seven days of onset, ready to give written consent and age group 20 years and above were included. Patients who were diagnosed of ischemic stroke after seven days, history of any Ischemic stroke in the past and severely ill patients were excluded.
[033] In another embodiment, Data collection: a predesigned and pretested modified questionnaire for WHO stepwise approach to chronic disease risk factor surveillance and WHO stepwise approach to stroke surveillance were used for data collection.
[034] In another embodiment, biochemical investigation including blood sugar of cases and control were done using auto-analyzers.
[035] In another embodiment, analysis: Quantitative parameters such as age were expressed as mean and standard deviation. To ascertain association of risk factor with stroke, the analysis was conducted through calculation of odd ratio (OR) and confidence internal (CI) by using SPSS 22.0 program. In evaluating the risk factor, significant p-values were taken as less than 0.05.
[036] The present disclosure described herein above has several technical advantages including, but not limited to,
? In another embodiment, age was an important and significant risk factor among non-modifiable factors.
? Among modifiable risk factor like diabetes mellitus was found to be a significant risk factor in patients with Ischemic stroke.
? It is estimated that the burden of stroke is expected to increase in the poor and middle income countries.
? It is very essential to estimate the risk factors for better understanding the pathophysiology, to make proper prevention strategies to decrease the burden of stroke in the population.
[037] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[038] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.

We Claim:

1. A case control method for Diabetes mellitus as a risk factor for ischemic stroke comprising the steps : a) The sample size was calculated for matched case control (1:1 ratio) by nMaster software; wherein a minimum number of required pairs of case and control came out to be 189; b) Controls (1:1) were selected from the same hospital but admitted for conditions other than ischemic stroke; c) Inclusion/exclusion criteria: patients diagnosed with first ischemic stroke or transient ischemic attack (TIA) within seven days of onset, ready to give written consent and age group 20 years and above were included; d) Data collection: a predesigned and pretested modified questionnaire for WHO stepwise approach to chronic disease risk factor surveillance and WHO stepwise approach to stroke surveillance were used for data collection; e) Analysis: quantitative parameters such as age were expressed as mean and standard deviation; To ascertain association of risk factor with stroke, the analysis was conducted through calculation of odd ratio (OR) and confidence internal (CI) by using SPSS 22.0 program; f) Among modifiable risk factor like diabetes mellitus was found to be a significant risk factor in patients with Ischemic stroke; wherein therefore it is very essential to estimate the risk factors for better understanding the pathophysiology, to make proper prevention strategies to decrease the burden of stroke in the population.

2. The case control method for Diabetes mellitus as a risk factor for ischemic stroke as claimed in claim 1, wherein socio-demographic characteristics of the cases and controls. 128 (67.7%) were male and 61(32.3%) were female in both groups.

3. The case control method for Diabetes mellitus as a risk factor for ischemic stroke as claimed in claim 1, wherein all subjects were distributed in a range of 20 years age groups: 20-40, 40-60, 60-80 and >80 in both case and control.

4. The case control method for Diabetes mellitus as a risk factor for ischemic stroke as claimed in claim 1, wherein among cases there were equal no of subjects in the age group of 40-60 and 60-80 year (43.4% in both) whereas among controls maximum respondents were in the age group of 40-60 years (47.1%).
5. The case control method for Diabetes mellitus as a risk factor for ischemic stroke as claimed in claim 1, wherein least participants were found in >80 years age group among both cases and controls. Mean age of case and control were 58.86±13.03 and 58.21±12.67.