ABSTRACT
Background: Several clinical trials have shown that lifestyle modifications lower blood pressure, have effect on weight and lipid profile, leading to improvement in cardiovascular risk factors. This study was undertaken to determine the effect of structured lifestyle modification on cardiovascular risk factors in T2DM patients presenting to the GOPC of IUTH.
Study Design/Setting: The study was carried out among T2DM patients 25 years and above presenting to the GOPC of IUTH with cardiovascular risk factors.
Materials/Method: The study was a randomized controlled trial where subjects were randomly allocated to intervention and control groups. A total of 352 T2DM patients were enrolled into the study. The subjects were randomized to either the intervention (n= 176) or control group (n= 176) using systematic random sampling technique. Randomization was done using Microsoft excel computer generated random numbers. The intervention offered was structured lifestyle modification counselling and follow-up for a period of 12 weeks. Data was collected on each subject’s socio-demographic, medical and lifestyle habits via a questionnaire. Physical examination, fasting blood glucose and serum lipid profile were done. Subjects were followed up for twelve weeks after which physical examination and laboratory investigations were repeated. The primary outcomes were changes in lifestyle habits and reduction in blood pressure, weight and improvement in lipid profile. Chi-square and t-tests were used for analysis. Data was analyzed on an intention to treat basis. A p-value of <0.05 was considered significant in all analysis.
Results: After twelve weeks,there was significant differences between groups; the mean systolic blood pressure -6.5 mmHg (p= 0.017), mean weight -1.78kg (p = 0.015), mean HDL-C (p= 0.002) and mean TG (p = 0.04).
Overall significant improvements in healthy lifestyle habits were notable in the intervention group.
Conclusion: Patients with T2DM can make and sustain multiple lifestyle modifications during a period of twelve weeks, which can reduce and control blood pressure, reduce weight andimprove serum HDL-C level. Management of modifiable cardiovascular risk factors is therefore of key importance in all patients with T2DM. Structured lifestyle modification in clinical setting can enable type 2 diabetic patients with cardiovascular risk factors to adopt long-term healthier lifestyles.
CHAPTER ONE
1.0 INTRODUCTION
1.1 Background
Diabetes mellitus is a metabolic disorder of multiple aetiology characterized by chronic hyperglycaemia with disturbances in carbohydrate, fat and protein metabolism as a result of defects in insulin secretion, insulin action or both.1There are four classifications of diabetes mellitus (DM): type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), gestational diabetes mellitus (GDM) and other specific types.2,3 Risk factors for type 2 DM include: impaired fasting glucose, impaired glucose tolerance, family history of DM, body mass index (BMI) greater than 25kg/m2, sedentary lifestyle, hypertension, dyslipidaemia, history of GDM or large for gestational age infant, polycystic ovary syndrome, Black race, Latin Americans, Native Americans and Asian-Pacific islanders.3Peripheral resistance to insulin and pancreatic beta-cell dysfunction are the hallmarks of DM. The beta-cell dysfunction, which is worsened by chronic hyperglycaemia, is primarily responsible for its progression.4
Symptoms of marked hyperglycaemia include polyuria, polydipsia, weight loss, polyphagia and blurred vision. Acute life-threatening consequences of uncontrolled DM are diabetic ketoacidosis and hyperglycaemic hyperosmolar state. Chronic complications can be microvascular diseases like nephropathy, retinopathy, neuropathy; and macrovascular diseases which include coronary heart disease (CHD), peripheral vascular disease and stroke.5
The 2011 revised criteria by the Expert Committee on Diagnosis and Classification of Diabetes Mellitus, recommends the diagnosis of diabetes based on: Two fasting plasma glucose (FPG) levels of ≥126 mg/dL (7.0 mmol/L) or two 2-hours postprandial glucose (2hPPG) reading of ≥200 mg/dL (11.1 mmol/L) after a glucose load of 75 g, or two random glucose readings of ≥200 mg/dL (11.1mmol/L) or glycosylated hemoglobin (HbA1c) ≥6.5% or in a patient with classic symptoms of hyperglycemia or hyperglycaemic crisis, a random plasma glucose of 200 mg/dL (11.1 mmol/L).2,6Cardiovascular risk factors are common and poorly controlled in patients with diabetes.2 People with type 2 diabetes mellitus have increased risk of high blood pressure, lipid problems, and obesity, which contribute to their high rates of cardiovascular disease (CVD). The leading CVD risk factor is raised blood pressure, to which 13% of global deaths is attributed to, followed by tobacco use (9%), raised blood glucose (6%), physical inactivity (6%) and overweight and obesity (5%).7
Cardiovascular disease is a major complication of diabetes mellitus and the leading cause of early death among people with the disease, with about 65% of people with diabetes mellitus dying from heart disease and stroke. Adults with T2DM are two to four times more likely to develop heart disease or suffer a stroke than people without DM. Smoking doubles the risk of cardiovascular disease in people with diabetes mellitus.4Dyslipidaemia, an established risk factor for cardiovascular disease, is very common in patients with type 2 diabetes, affecting almost 50% of these patients.8Type 2 diabetes mellitus is associated with various patterns of dyslipidaemia. Presence of lipoprotein disorders is a very common finding in diabetic patients causing morbidity and mortality from cardiovascular diseases. Moderate hypertriglyceridaemia and a lower level of high density lipoprotein cholesterol characterize most type 2 diabetic patients, with hypertriglyceridaemia being an independent risk factor for coronary heart disease.8 Because of the additive cardiovascular risk of hyperglycaemia and hyperlipidaemia, lipid abnormalities should be aggressively detected and treated as part of comprehensive care in diabetes mellitus in order to reduce the additional cardiovascular risk. Improved control of cholesterol or blood lipids like low density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) can reduce CVD complications by 20 to 50%.1 This leads to the expectation that treatment of elevated lipid levels will allow patients with diabetes to live longer, healthier lives.8 The National Diabetes Education Program (NDEP) campaign focuses on comprehensive control of diabetes and urges optimal management of glycated haemoglobin (HbA1c), a measure of average blood glucose, blood pressure and cholesterol.9
Hypertension, defined as blood pressure ≥140/90 mmHg is an extremely common co-morbid condition in diabetes mellitus, affecting 20-60% of patients with diabetes, depending on obesity, ethnicity and age.10Hypertension has long been recognized as a major risk factor for cardiovascular disease. When a patient has both hypertension and diabetes mellitus, the risk of cardiovascular disease doubles.11Blood pressure control reduces the risk of cardiovascular disease among persons with diabetes mellitus. In general, for every 10 mmHg reduction in systolic blood pressure, the risk of complication from diabetes mellitus reduces by twelve percent.1Patients with diabetes should achieve a target blood pressure of less than 130/80 mmHg. Patients with diabetes mellitus whose systolic blood pressure is between 130 and 139 mmHg or whose diastolic blood pressure is between 80 and 89 mmHg are candidates for a three-month trial of lifestyle modifications.5The seventh report of the Joint National Committee (JNC-7) on the prevention, detection, evaluation and treatment of high blood pressure recommends lifestyle modification for all patients with hypertension which is a cardiovascular risk in patients with type 2 diabetes mellitus.12,13
Exercise should be an integral component in the management of diabetes mellitus because it is beneficial in terms of mobility, balance, reduced risk of fall in older people, psycho-social benefits, and enhances quality of life.13Regular exercise has been shown to improve blood glucose control, reduce cardiovascular risk factors, contribute to weight loss, and improve well-being.14Exercise has been shown to be beneficial in individuals with diabetes mellitus with observed increases in circulating HDL-C and reductions in systolic and diastolic blood pressures.14The American Diabetes Association (ADA) recommends that people with diabetes should be advised to perform at least 150 minutes/week of moderate-intensity aerobic physical activity (50-70% of maximum heart rate). In the absence of contraindications, people with type 2 diabetes should be encouraged to perform resistance training three times per week.14
Studies have shown that lifestyle interventions can produce long term weight loss and improvement in fitness and sustained beneficial effects on CVD risk factors in individuals with type 2 diabetes mellitus.15 Intensive lifestyle interventions provide great reduction in occurrence of hypertension, along with a modest reduction in CVD risk factors, and have a favourable safety profile. Aggressive management of all CVD risk factors, is therefore generally necessary in individuals with diabetes mellitus.16Achieving this goal requires a comprehensive, coordinated, patient-centred approach on the part of the health care system.
1.2 Research Problem
The increasing number of people with type 2 diabetes mellitus is a serious concern all over the world.17 Diabetes threatens the achievement of the millennium development goals (MDG), increases the risk of developing tuberculosis, and is closely linked with other infections.1 Although the exact magnitude of the problem in Africa is not well understood, DM is a serious threat to public health throughout the continent.17
Diabetes mellitus has a profound impact on life expectancy. A person diagnosed with T2DM in middle age (40-60 years) stands to lose about 10 years of life expectancy.18Despite advances made in the prevention and management of cardiovascular disease, people with diabetes mellitus continue to have alarmingly high morbidity and mortality secondary to cardiovascular disease.
Epidemiologic studies have demonstrated that diabetes mellitus is an independent risk factor for cardiovascular disease and that it amplifies the effects of other common risk factors, such as smoking, hypertension and hypercholesterolaemia. About 80% of people with diabetes live in low and middle income countries.1 The greatest number of people with diabetes are between 40 and 59 years of age.19 The mortality associated with a coronary event in people with diabetes mellitus is significantly higher than the mortality in non-diabetic individuals.19 Seventy eight percent of type 2 diabetic patients die from cardiovascular disease, mainly from premature atherosclerosis which involves dyslipidaemia.18 Treatment of elevated lipid levels and other cardiovascular risk factors will allow patients with diabetes mellitus to live longer healthier lives.8
1.3 Research Question
The study seeks to answer the following research question: “does structured lifestyle changes in respect to diet, alcohol consumption, exercise, sleep and cigarette smoking have positive effect on cardiovascular risk factors such as hypertension, overweight & obesity and serum lipid profile of type 2 diabetic patients attending the general outpatient clinic of Imo state Teaching Hospital?”
1.4 Null Hypothesis
The study was carried out to test the hypothesis that structured lifestyle modification with respect to diet, exercise, sleep, alcohol consumption and cigarette smoking have no positive effect on cardiovascular risk factors such as hypertension, overweight and obesity and dyslipidaemia in patients with type 2 diabetes mellitus attending the general outpatient clinic of Imo state Teaching Hospital.
1.5 Alternate Hypothesis
Structured lifestyle modification with respect to diet, exercise, sleep, alcohol consumption and cigarette smoking have positive effect on cardiovascular risk factors such as hypertension, overweight and obesity and dyslipidaemia in patients with type 2 diabetes mellitus attending the general outpatient clinic of Imo state Teaching Hospital.
1.6 Aim and Objectives
1.6.1 Aim
To assess the effect of structured lifestyle modification in the management of cardiovascular risk factors among type 2 diabetic patients that attend the General Outpatient Clinic (GOPC) of Imo state Teaching Hospital (IUTH) in order to formulate guidelines for its adoption and recommend routine screening as part of holistic management in these patients.
1.6.2 Objectives
1. To describe the socio-demographic characteristics of study participants and their relationship with cardiovascular risk factors- hypertension, dyslipidaemia and overweight/obesity.
2. To assess compliance with structured lifestyle modification in the intervention group of patients with type 2 DM.
3. To compare the changes in blood pressure, weight and lipid profile in the intervention group with that of the control group.
4. To determine the short-term effect of structured lifestyle modification on blood pressure, overweight/obesity and dyslipidaemia in type 2 diabetic patients.
1.7 Justification of the Study
The main justification of the study is that findings may lead to recommendations that may prevent the development of cardiovascular risk factors in patients with T2DM. The Family
Physician is a specialist who possesses skills and knowledge that enables him to provide continuing, comprehensive and coordinated care. Family Medicine in particular, emphasizes preventive healthcare. There are potential benefits of modifying cardiovascular risk factors among individuals with known cardiovascular disease such as in diabetes mellitus. Treatment of cardiovascular risk factors appears to be highly cost-effective if assessed on time with early commencement of lifestyle modification to prevent complications. Assessment of cardiovascular risk in routine clinical practice is beneficial as this helps in reassuring low-risk individuals, motivating high-risk individuals to modify their lifestyle or adhere to medical therapy, and tracking an individual’s progress as risk factors come under control.
Early identification and treatment of cardiovascular risk factors provides significant opportunity in improving patients’ care and cardiovascular risk stratification in moderate to high-risk groups. The adoption of effective behavioural actions to contain the progression of cardiovascular risk in diabetes mellitus is necessary to reduce the high levels of morbidity and mortality due to cardiovascular diseases. Adherence to lifestyle modifications constitutes an essential strategy in this struggle. It is possible to achieve reductions in elevated blood pressure, overweight and obesity, and to some extent elevated blood cholesterol through non pharmacological interventions which can be implemented in primary care setting. This study seeks to provide data on the effect of structured lifestyle interventions compared with routine care on cardiovascular risk factors in patients with T2DM, in primary care.
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