F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.135187.1 Study Protocol Articles Estimation of the prevalence of risk factors of type 2 diabetes in the population from age  group 30-50 years in Wardha District

[version 1; peer review: awaiting peer review]

 Kshirsagar Kalyani Conceptualization Visualization Writing – Original Draft Preparation https://orcid.org/0009-0009-4138-2870 a 1 Mude Gaurav Conceptualization Validation Writing – Review & Editing b 2 Clinical Research, School of Allied Health Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India Pharmacology, , Datta Meghe College of Pharmacy, Datta Meghe Institute of Higher Education and Research,, Wardha, Maharashtra, India kalyanikshirsagar5695@gmail.com gaurav.pharmacy@dmiher.edu.in

No competing interests were disclosed.

 17 7 2023 2023 12 840 10 7 2023 Copyright: © 2023 Kshirsagar K and Mude G 2023 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: One of the most prevalent long-lasting illnesses globally is type 2 diabetes mellitus (T2DM), and the population of diabetic people is increasing. A sizable population also has impaired glucose tolerance (IGT); of which many will eventually acquire type 2 diabetes. Population expansion, aging, urbanization, a rise in physical inactivity and obesity are all contributing factors to the rising incidence of diabetes worldwide. In April 2021, World Health Organization unveiled the Global Diabetes Compact, a worldwide initiative with an emphasis on supporting low-and middle-income countries. Its objective is to make notable advancements in diagnosing and avoiding diabetes. Through the compact, all parties are coming together to work toward the collective objective of lowering the risk of developing diabetes and ensuring that everyone who develops the disease has access to affordable, comprehensive, high-quality, and equitable care.

Methods: This study focuses on assessing the frequency of risk factors for type 2 diabetes in Wardha district. It is an observational study by using risk factor checklist we will assess the prevalence of risk factors related to diabetes.

Conclusions: The study’s strength lies in the use of a systematic risk factor checklist which will ensure consistency in data collection and minimize bias. The use of large sample size will also improve the precision of the study and increase the generalizability of the result.

 Diabetes mellitus Obesity Glucose Tolerance Prevalence Illnesses. The author(s) declared that no grants were involved in supporting this work. Introduction

A long-term condition of glucose metabolism resulting in serious clinical upshot is diabetes mellitus. Microvascular (nephropathy, neuropathy, and retinopathy) and macrovascular (ischemic heart disease, peripheral vascular disease, and stroke) outcomes are among the multi-system consequences of diabetes. 1 For those who have diabetes, even a little sickness can result in blood sugar levels that are dangerously high. Hyperosmolar hyperglycemia or diabetic ketoacidosis are two potentially fatal consequences that might result from this. 2 Asian communities experience diabetes at an earlier age than the white population does, hence the disease’s morbidity and mortality, as well as its complications, are more frequent among young Asian individuals. 3 Over the past 20 years, the quantity of persons with diabetes has worldwide doubled. 4 The rapid increase of type 2 diabetes in kids, teenagers, and adults is one of the most worrying features as it affect the other organs. 4 The classic risk factors for T2DM, such as behavioral, lifestyle, and genetic risk factors, are still important for its cause. 4 One of the most significant health issues associated with diabetes is diabetic nephropathy, which frequently results in end-stage renal failure. The other primary cause of end-stage renal disease and glomerulosclerosis, which is a worldwide occurrence, is advanced diabetic nephropathy. 5

There are 3 clinically different kinds of diabetic conditions (Type 1, Type 2 and Gestational diabetes). Type 1: autoimmune beta-cell death in the pancreas causes type 1 diabetes, which is distinguished by a complete lack of insulin production. In the condition of type 2 diabetes, the inability of the hormone insulin to control blood glucose levels results in tissue damage, increased cardiometabolic risk, and in the absence of therapy, an increased chance of early mortality. Clinical studies in industrialized nations by the middle of the 20 th century had established a consensus that diabetes was an “adult-onset” illness predominantly caused by genetics and adult lifestyle. Obesity was the biggest risk factor, accounting for over 80% of instances where it was deemed the primary cause, 6 research in the following years gave rise to the idea that diabetes is a “two-hit” illness that affects both muscle tissue that is insulin resistant and the pancreatic beta cell’s inability to generate enough insulin to overcome this resistance. 6 More insulin is first generated to bring the blood sugar level to normal. But in the case of obese people particularly, this reaction is insufficient to overcome insulin sensitivity, leading to an increase in the liver’s synthesis of glucose. As a result, “prediabetes” develops, a state in which the glucose level is raised but still within the T2DM range. Protein, fat, and glucose metabolism become disturbed as the condition develops. When the beta cells are unable to counteract insulin resistance with increased insulin secretion, hyperglycemia (high blood sugar levels) ensues. T2DM is characterized by the long-term, gradual reduction in β-cell mass and function accompanied by hyperglycemia. 7

The chance of developing diabetes can be increased by a number of variables, such as weight, genetics, and medical disorders. 8 A glucose intolerance initially identified during pregnancy is known as gestational diabetes mellitus (GDM). It is known to significantly increase maternal and infant morbidity and death, and it is increasingly a public health problem in low- and middle-income nations. 9 The process of pregnancy itself causes changes in the mother’s glucose metabolism and insulin sensitivity, increasing the need for the production of insulin. 9

Due to direct medical costs as well as missed wages and income, diabetes and its complications cause enormous financial losses for persons who have the condition, their families, healthcare systems, and national economies. 10 One of the main economic factors, along with inpatient and outpatient treatment, is the increasing expense of analog insulins 1, which are commonly prescribed despite the lack of evidence that they provide substantial advantages over human insulin, which is less expensive. 10

Currently, the majority of significant diabetes health initiatives focus on integrating diabetes care into already-established disease-prevention programs, such as those against heart disease and hypertension, which share similar risk factors eg: The WHO global diabetes compact. 11 The purpose of such efforts is to provide active educational campaigns for diagnosed patients about the risk factors they face and coordinate processes for the proper referral of patients to experts when needed, despite the numerous studies that have been published on the rising prevalence of diabetes and the widespread acceptance that it has become a serious global health issue. A definite link between effective disease management and a reduction in disease burden has been shown by several significant research. 12 Such studies provide compelling evidence that, with the right treatment plan, the economic and societal costs associated with diabetes are at least partially preventable. 12

In adults aged 20 to 79, the estimated worldwide prevalence of diabetes was 10.5 percent (536.6 million) in 2021 and was projected to rise to 12.2 percent (783.2 million) in 2045. 13 The prevalence of diabetes was similar between the sexes and was greater in those between the ages of 75 and 79. According to projections, in 2021, high-income countries (11.1%) had a higher frequency than low-income ones (5.5%) and urban regions (12.1%) had a higher prevalence than rural ones (8.3%). 13 The aim of the current study is to estimate the prevalence of risk factors of T2DM.

Objective

To determine the frequency of risk factor for type 2 diabetes.

To state the occurrence of risk factors of diabetes.

Protocol Methodology

The motive of this study is to determine the frequency of risk factors of Type 2 Diabetes. The study will be conducted among the overall Diabetic population of Wardha District from different government and private hospitals. This will be a cross sectional observational study, performed over a period of 4 months. Conceptual research (observing and analysing already present data) on Type 2 Diabetes will be done.

The evaluation of the prevalence of risk factors of T2DM will be done through face-to-face interviews by using a risk factor checklist which will be filled by the participants (see Extended data 24 ).

 Ethical considerations

Approval for this protocol has been gained by the Institutional Ethics Committee (Ref. No. DMIHER (DU)/IEC/2023/591 on 06/02/2023) of Datta Meghe Institute of Higher Education and Research Sawangi (M) Wardha- 442107 Maharashtra, India. An Inform Consent Form (ICF) will be filled by all the subjects after explaining the purpose of the study (see Extended data 25 ).

 Participants

The sample size will depend on convenience sampling. Participants visiting tertiary study sites between February to June 2024 will be recruited.

 Selection of subjects

Inclusion:

Age group between 30 – 50 years.

HbA1c above 8% (HbA1c is called Glycosylated hemoglobin and measures long-term sugar levels).

An Equal number of men and women.

Family history of diabetes.

BMI over 25 kg/m 2.

Exclusion:

Must not have any cardiovascular events such as stroke, or myocardial infarction.

Subjects above 50 years.

Pregnant women.

Local resident less than 3 years.

should not be hypertensive.

should not have hypo and hyperthyroid.

should not undergo any surgery.

Should not take any other medicines other than for diabetes.

Method of data collection

The researcher will introduce herself to the subject. Following an explanation of the study’s objective to all volunteers, informed consent will be obtained. The participant will complete the risk factor checklist which includes a list of risk factors associated with diabetes (eg: Obesity, History, Hypertension etc). The gathered information using risk factor checklist will be compiled and examined.

 Data analysis

The Statistical Package for social sciences (SPSS) and Excel will be used to analyze the data using statistical analysis including mean, standard deviation, frequency, proportion, and percentage as well as inferential statistics including 2 tests, factor analysis, and discriminant analysis.

 Dissemination

The results will be published in an indexed journal.

 Study status

The study is yet to start.

 Discussion Risk factors

The emergence of T2DM is affected by a variety of interconnected metabolic, environmental, and genetic risk factors. Those at higher risk include those who have a significant family history of diabetes mellitus, are obese, inactive, and older. Minority communities are also more vulnerable due to impacts from malnutrition and exercise habits, as well as family history and genetics. If a person has insulin resistance, they are having higher risk of develop type 2 diabetes and impaired glucose tolerance. 14 People with insulin resistance have many of the same risk factors that are present in type 2 diabetes. 14 These includes prothrombic condition, polycystic ovarian syndrome, hyperinsulinemia, hypertension, hyperuricemia, and atherogenic dyslipidemia. 14 Skin tags and acanthosis nigricans were the most prevalent non-infectious conditions, whereas fungal infections were the most frequent infections linked to diabetes. 15 Unrestricted meals and snacks should be provided to elderly adults who are at risk of malnutrition, and medicines should be changed as needed to regulate blood sugar levels. 16

Diet: According to data from the Nurses’ Health Study (NHS), 17 food quality has a substantial influence on the development of diabetes in addition to body mass index (BMI) and several other risk factors. While higher consumption of polyunsaturated fat and cereal fiber is linked to a decreased risk of developing diabetes, trans-fat consumption and higher dietary glycaemic load in particular are linked to a greater risk. 18 According to the NHS findings, consuming more nuts and peanut butter can reduce the risk of developing T2DM, but consuming more beverages with added sugar is associated with both weight gain and a higher risk of developing type 2 diabetes. Increased consumption of potatoes and French fries is positively connected with a higher risk of type 2 diabetes; this association is greater in obese individuals. In illness, prevention and healthcare, nutrients play a crucial role. Antioxidants are produced by vitamin C. Diabetes is concerned with the inherent relationship between vitamin C and glucose. 19

Smoking and Alcohol Consumption: Smoking and alcohol use are becoming more and more prevalent worldwide and are raising more and more public concerns as a result of fast globalization and socioeconomic growth 18 also the relation between active smoking and increases risk of T2DM has been found in meta-analysis. 18 Even if their BMI is within the normal range, smokers are more likely than non-smokers to acquire abdominal fat. This is because smoking has an antiestrogenic impact that can interrupt hormonal balance, which in turn promotes belly fat and the onset of type 2 diabetes is closely correlated with both overall and abdominal obesity. 18 It is vital and necessary to lower the high smoking rates throughout the world, chiefly in progressive nations, to prevent the worldwide spread of type 2 diabetes and its comorbidities. 18

As indicated by the fact that we now sleep for an average of 408 min each night, 90 min less than we did a century ago, modern civilization commonly encounters sleep deprivation. 20 Some people have hypothesized that our society is sleep-deprived because more than 30% of adults say they sleep for fewer than 6 hrs every night. 20 This transformation has been influenced by factors like rising ambient light levels, longer workdays, and commutes, an increase in shift and night time employment, as well as the growth of television, radio, and the internet. The hormonal and metabolic effects of less sleep are just now starting to be understood. Short-term partial sleep deprivation, according to physiological evidence, causes pronounced changes in endocrine function and metabolic, including lower glucose tolerance, and increased insulin-term sleep deprivation may increase a person’s risk of developing overt clinical diabetes. 20

Managing diabetes

The first step in effectively treating diabetes is receiving a prompt diagnosis; the longer someone waits before seeking treatment and receiving a diagnosis, the more seriously their health is likely to deteriorate. 10 Consequently, primary healthcare clinics are thought to have simple access to fundamental diagnostics like blood glucose testing. Numerous accessible therapies can enhance a patient’s outcomes, some of these interventions include controlling blood sugar levels through exercise, diet, and if necessary, routine screening for damaged kidneys, eyes, and feet, medication to enable early treatment, and controlling blood lipids. All of these interventions aim to reduce the risk of cardiovascular disease and other complications. 10 Psychosocial factors substantially impact the therapeutic efficacy and long-term prognosis for diabetes. Furthermore, effective diabetes management has been linked to notable enhancement in one’s physical, social, and mental health. 21 Examples of type 2 diabetes drugs are listed below.

The first drug used for treatment of type 2 diabetes is metformin (Fortamet, Glumetza, etc.). It works by decreasing the amount of glucose the liver produces and improving insulin sensitivity so that insulin is utilized by the body more effectively.

In addition to diabetes medications, BP and hypocholesteraemia medication and low-dose aspirin may be suggested by doctors to help prevent heart and vascular disease. 22

All of the herbal preparations that are used in the treatment of diabetes are known as antidiabetic medications and are utilised by all ayurvedic practitioners. The polyherbal drug is made up of 17 antidiabetic plants that have been shown to regulate diabetes-induced glucose metabolism problems. 23

Ethical considerations

Approval for this protocol has been gained by the Institutional Ethics Committee (Ref. No. DMIHER (DU)/IEC/2023/591 on 06/02/2023) of Datta Meghe Institute of Higher Education and Research Sawangi (M) Wardha- 442107 Maharashtra, India.

 Data availability Underlying data

No data are associated with this article.

 Extended data

Zenodo: checklist for diabetes. https://zenodo.org/record/7997226 . 24

Zenodo: English ICF and consent form. https://zenodo.org/record/8019481 . 25

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

 References Forouhi NG Wareham NJ : Epidemiology of diabetes. Med Abingdon Engl UK Ed. 2014 Dec;42(12):698–702. 10.1016/j.mpmed.2014.09.007 Agrawal D : Diabetes and covid-19: A review. Int J Res Pharm Sci. 2020;11:376–379. 10.26452/ijrps.v11iSPL1.2729 Ramachandran A Ma RCW Snehalatha C : Diabetes in Asia. Lancet Lond Engl. 2010 Jan 30;375(9712):408–418. 10.1016/S0140-6736(09)60937-5 Zimmet PZ Magliano DJ Herman WH : Diabetes: a 21st century challenge. Lancet Diabetes Endocrinol. 2014 Jan;2(1):56–64. 10.1016/S2213-8587(13)70112-8 Warjukar P Jain P Kute P : Study of Microalbuminuria and Uric Acid in Type 2 Diabetes Mellitus. Int J Curr Res Rev. 2020;56–65. 10.31782/IJCRR.2020.5665 Deshpande AD Harris-Hayes M Schootman M : Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254–1264. 18801858 10.2522/ptj.20080020 PMC3870323 Dendup T Feng X Clingan S : Environmental Risk Factors for Developing Type 2 Diabetes Mellitus: A Systematic Review. Int J Environ Res Public Health. 2018 Jan;15(1):78. 29304014 10.3390/ijerph15010078 PMC5800177 BMI - A Significant Risk Factor For Type 2 Diabetes - Blog - HealthifyMe. [cited 2023 Apr 30]. Reference Source Atlaw D Sahiledengle B Assefa T : Incidence and risk factors of gestational diabetes mellitus in Goba town, Southeast Ethiopia: a prospective cohort study. BMJ Open. 2022 Sep;12(9):e060694. 36167396 10.1136/bmjopen-2021-060694 PMC9516079 World Health Organization: Global report on diabetes. Geneva: World Health Organization;2016 [cited 2023 Apr 26];83. Reference Source The WHO Global Diabetes Compact. [cited 2023 May 31]. Reference Source Bjork S Kapur A King H : Global policy: aspects of diabetes in India. Health Policy. 2003 Oct 1;66(1):61–72. 14499166 10.1016/S0168-8510(03)00044-7 Sun H Saeedi P Karuranga S : IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. 34879977 10.1016/j.diabres.2021.109119 Fletcher B Gulanick M Lamendola C : Risk factors for type 2 diabetes mellitus. J Cardiovasc Nurs. 2002 Jan;16(2):17–23. 10.1097/00005082-200201000-00003 Henry D Singh A : A study of pattern of cutaneous manifestations in patients with diabetes mellitus. J Pak Assoc Dermatol. 2020 Aug 7;30(1):161–166. Hornick T Aron DC : Managing diabetes in the elderly: go easy, individualize. Cleve Clin J Med. 2008 Jan 1;75(1):70–78. 18236732 10.3949/ccjm.75.1.70 Nurses’ Health Study. [cited 2023 May 31]. Reference Source Bi Y Wang T Xu M : Advanced research on risk factors of type 2 diabetes. Diabetes Metab Res Rev. 2012;28(s2):32–39. 10.1002/dmrr.2352 Wagh SP Bhagat SP Bankar N : Role of Vitamin-C Supplementation in Type II Diabetes Mellitus. Int J Curr Res Rev. 2020;12(13):61–64. 10.31782/IJCRR.2020.121311 Yaggi HK Araujo AB McKinlay JB : Sleep Duration as a Risk Factor for the Development of Type 2 Diabetes. Diabetes Care. 2006 Mar 1;29(3):657–661. Kalra S Sridhar GR Balhara YPS : National recommendations: Psychosocial management of diabetes in India. Indian J Endocrinol Metab. 2013;17(3):376–395. 23869293 10.4103/2230-8210.111608 PMC3712367 Type 2 diabetes - Diagnosis and treatment - Mayo Clinic. [cited 2023 May 7]. Reference Source [PDF] Polyherbal antidiabetic drug: An approach to cure diabetes|Semantic Scholar. [cited 2023 Jun 2]. Reference Source Kshirsagar K : checklist for diabetes (Version v1). Zenodo. 2023. 10.5281/zenodo.7997226 Kshirsagar K : English ICF (Version v1). Zenodo. 2023. 10.5281/zenodo.8019481