Abstract

Diabetes management is being further studied as the prevalence of the disease keeps increasing.  To achieve better management of diabetes, research is conducted to ensure the most up to date information.  With diabetes, there are many factors that influence hemoglobin A1C levels.  These factors, according to the American Diabetes Association, include interventions such as diet, exercise, and medication management.  The focus of this research proposal is to compare which healthy lifestyle change better yields to a reduction in hemoglobin A1C.  The main objective is to identify if exercise or dietary modification has more of an effect on hemoglobin AIC levels in adults diagnosed with type 2 diabetes vs. both interventions combined.  The proposal discusses current knowledge, ethical considerations, the Iowa Model of Evidence-Based Practice, literature reviews, and findings/conclusions of the conducted research.  Continuing research on diabetes aids to provide new information on the disease process and improve clinical outcomes.

PICOT

In adults diagnosed with type 2 diabetes (P) how does physical exercise (I) compared to dietary modifications (C) reduce hemoglobin A1C (O) within 1 year of implementation (T)?

In this research paper, the population of concern is middle-aged adults diagnosed with type 2 diabetes.  The topic of concern is management of diabetes through diet and exercise lowering hemoglobin A1C levels.  The goal of this research is to compare and evaluate evidence-based articles to conclude which non-pharmacological intervention has best outcomes with regards to hemoglobin A1C in the identified population.

Background

Diabetes has become a major health issue worldwide.  The American Diabetes Association 2015 statistics states, 30.3 million Americans have diabetes.  However, only 23.1 million of those 30.3 million are diagnosed, leaving the other 7.2 million undiagnosed (American Diabetes Association).  This number is expected to grow.  With the increasing number in this chronic disease, it is important to conduct new research to achieve better management of diabetes, and to ensure the most up to date information.

Diabetes mellitus can be classified into two categories: type I and type II diabetes.  In diabetes type I, the pancreatic beta cells do not produce insulin.  Insulin is a hormone produced by cells in the pancreas.  Type I is also called insulin dependent, as there is absolutely no insulin produced. In type II diabetes, there is little insulin produced by the pancreas which causes poor blood sugar regulation throughout the body.  Type II is referred to as insulin deficient because there is a lack of insulin.  In type II diabetes, your body doesn’t make enough insulin or doesn’t use insulin well.  Too much glucose then stays in your body, and not enough reaches your cells (NIDDK,2017).  Most people with a diabetic diagnosis have type II diabetes (CDC,2019). The term HbA1c is used within diabetes.  HbA1c is glycated haemoglobin which is produced throughout your body and can be measured to give an overview of your average blood sugar levels over time.  This HbA1c blood test is used to confirm a diagnosis of type II diabetes and can also indicate a person at risk for developing diabetes (NIDDK, 2018).  A normal HbA1c level is below 5.7 percent whereas a person with type II diabetes will have an HbA1c level of 6.5 percent or greater A patient is considered at risk for diabetes, also called prediabetes, when their HbA1c level falls between 5.7 and 6.4 percent (NIDDK, 2018).

With diabetes being the seventh leading cause of death in the United States, it is important to be treated (CDC, 2019).  Diabetes is the leading cause of end-stage renal failure, lower limb amputations, and adult blindness (CDC, 2019).   If diabetes is left untreated, it can lead to complications.  These complications include skin and eye complications, neuropathy, foot complications, diabetic ketoacidosis, kidney disease, high blood pressure, and stroke (American Diabetes Association, 2019).  These complications are seen in both types of diabetes.  The major risk factors associated with type II diabetes are smoking, overweight and obesity, physical inactivity, high blood pressure, high cholesterol, and high blood glucose (CDC, 2017).

The American Diabetes Association uses diet, fitness, and medication management as its main interventions to manage diabetes.  Depending on hemoglobin A1C levels along with cardiovascular history, medication may or may not be needed, as some diabetics can control their blood sugar levels through healthy eating and exercise.  Diabetic medications are now recommended with patients who have a history of atherosclerotic cardiovascular disease (American Diabetes Association, 2017).  Medications for diabetes include insulin and oral medications which help the body maintain blood sugar levels.  With nonpharmacological interventions, physical activity and proper nutrition are the core interventions with management of type II diabetes.  According to the American Diabetes Association, patients that participate in regular aerobic exercise are more likely to reduce their hemoglobin A1C levels, blood pressure, triglycerides, and insulin resistance (American Diabetes Association, 2016).  As of 2019, the American Diabetes Association recommends that dietary key factors include: non-starchy vegetables, minimizing added sugars and refined grains, and to choose whole foods over highly processed foods as much as possible (American Diabetes Association, 2019).

Evidence Based Practice

Evidence-based practice (EBP) is used every day as a standard of health care.  Evidence-based practice is using the most current evidence on an everyday basis.  Nurses are constantly seeking new evidence that helps aid a patient’s outcomes.  All health care members work as a team to incorporate EBP to improve the providing care.  There are five steps of the evidence-based practice process.  These five steps are:

Ask the clinical question of interest using the PICO/T format

Collect the most relevant and best evidence

Critically appraise and synthesize the evidence

Integrate all evidence with clinical expertise and patient preference

Evaluate the practice decision or change (Lewis et al, 2017 p.7).

When there is little or no reliable evidence found in generalized research studies, health care providers can collaborate with research facilities to carry out new research that will aid patient care outcomes.  Nurses continue identifying new problems and potential answers to develop evidence-based research.  Evidence-based practice is an ongoing and continuously evolving process with rising new information found.

The current EBP for diabetes regarding nutrition is complex.  There hasn’t been any one specific diet alone that reduces HbA1c.  “Treatment goals, personal preferences, and the individual’s ability and willingness to make lifestyle changes must all be considered by clinicians and/or the educators when counseling and educating individuals with diabetes (Franz et al., 2017).  A study on EBP diabetes nutrition therapy recommendations states that the key individualization.  The study found that nutrition therapy interventions implemented by registered dietitians/nutritionists reduced HbA1c levels by an average of 1% to 2% (Franz et al., 2017). The reduction in hemoglobin AIC was greater with an earlier diagnosis, but still showed improvement within patients who have been diagnosed for years. The study determined that nutrition does play a key role in diabetes, but is a complex process that requires the health care provider, dietician, and patient to all correlate together to achieve the best outcomes

As far as EBP exercise goes, weight loss is frequently recommended as the solution to improve glycemic control.  “In persons with prediabetes, modest amounts of weight loss and regular physical activity are very effective in preventing or delaying the onset of type 2 diabetes (Franz et al., 2017).”  Weight loss in the studied patients ranged from 1.9kg to 4.8 kg at the year mark of the study.  The study determined that exercise is most likely to more beneficial for a patient with prediabetes or very early in the disease process (Franz et al., 2017).

The information obtained from this study on EBP in diabetes is supported by the American Diabetes Association.   The American Diabetes Association currently recommends that nutrition therapy and exercise go hand in hand to achieve the best outcomes on managing diabetes.  Evidence-based practice in diabetes continues to be an ongoing study.

Ethical Considerations (


Identify


ing


Risk


)

According to the Belmont Report, the term risk refers to a possibility that harm may occur (Belmont Report, 1979).  These risks can be high or low risk depending on probability.  The term benefit is used in reports that show a positive value whether in welfare or health.  Risk vs Benefit assessments are done in every research study, as they may affect the study subjects.  Risks can be harmful psychologically, physically, emotionally, and/or socially (Gray et al, 2017, p. 175).  Ethical considerations like risk factors and HIPPA should always be accounted for in any study to maintain patient safety and ethical research foundations.

An example of a risk with the EBP study mentioned would be a patient’s mental health. The American Diabetes Association standards of care recommend that treatment teams include a mental health professional with expertise with the disease (Ducat et al, 2014).  Blood sugar fluctuations, lifestyle adjustments, and new responsibilities with diabetes can really impact a patient’s mental health.  Patients with a diabetes diagnosis, no matter the type, are twice as likely to have depression than that of a someone without diabetes (Ducat et al, 2014).  With a newly diabetic patient, they may be experiencing many different emotions, and its important to make sure risks like this are not detrimental to both the research and the patient.

HIPPA

HIPPA is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (HHS. Gov. 2019).  The main objective for HIPPA is to protect patient privacy and health information.  Prior to research beginning, qualified participants are asked to sign permission that gives authorization to their public health information.  This health information can be used or disclosed in research studies.  Confidentiality is always an ethical concern in research.  When there is a breach in confidentiality, patients become at risk to be harmed psychologically, socially, and leads to a loss of trust (Grey et al, 2017 p.170).

Informed Consent Components

When obtaining informed consent, a patient is giving permission to allow treatment.  Informed consent allows patients to make an informed and voluntary decision prior to participation.  With informed consent obtained, it ensures that the patient understands what is to happen (Gray et al, 2017 p.170).  The Belmont Report states that, “participants should be given the opportunity to choose what shall or shall not happen to them, and the informed consent can be analyzed as information, comprehension, and voluntariness” (Belmont report, 1979).

Belmont Report

The Belmont Report was created with the focus of the protection of human beings within research studies (Belmont Report, 1979).  Prior to this report being released, there were many experiments done that are now considered unethical.  An example of a study that was found to be unethical is the Tuskegee Experiment.  The study involved a target population of 600 African American men who were told they have Syphilis and needed treatment. The men did not receive the proper medical treatment intentionally by the researchers who wanted to study the progress of the disease.  This 40-year unethical study was conducted without informed consent (CDC, 2015).  Its because of unethical research studies like the Tuskegee Experiment that the Belmont Report was created.  The Belmont Report consisted of three ethical principles.  These include respect for research participants, beneficence, and justice to protect human subjects (Belmont Report, 1979).  The Belmont Report set the guidelines and ethical principles that are significant to this day.

Literature Review

Diabetes mellitus type II is a growing world-wide health concern.  Type II is known as insulin resistant diabetes.  The purpose of conducting a literature review was to analyze the nonpharmacological and pharmacological interventions to decrease the A1C hemoglobin levels within the middle-age adult population who have type II diabetes.  Literature reviews can give credit to other researchers as well as provide findings in relation to the topic studied.  Reviews can also determine the value of evidence found in studies.  “Systematic reviews of randomized controlled trials are considered the strongest level of evidence to answer questions about interventions,” (Lewis et al, 2017).  The literature reviews for my research topic show the benefits of a healthy diet, exercise along with or without medication can help reduce serum glucose levels.  The following literature articles were gathered from Herzing University online library database and are considered reliable being no more than 5 years old.

Lifestyle Weight-Loss Intervention Outcomes in Overweight and Obese Adults with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

This article states that most type 2 diabetic patients are overweight.  While it’s not an ideal course of treatment for some patients, it is recommended for most patients.  This research article looks at the difference in hemoglobin A1C levels between weight loss levels of less than 5% body weight and greater than 5%.

Sample/Patient Population

Eleven trials were considered in this analysis. 6,754  total participants met study criteria for this (Franz, 2015).

Intervention

Studies that showed benefits included interventions of regular physical activity.

Duration of the intervention varies

Each study was required to have a minimum of 12 months.

Outcome

The studies found that a weight loss of >5% showed beneficial effects on HbA1c, lipids, and blood pressure. (Franz,2015).

Type 2 Diabetes; Short bursts of high-intensity exercise does more for type 2 diabetes

This study looked at the difference in patients hemoglobin levels between high intensity and low intensity regular exercise.  NewsRx LLC reports that “Exercise is known to help reduce cholesterol and weight as well as manage Type 2 diabetes. (Taylor, & et al. (2014) states “Exercise training is effective for improving physical fitness and physical function in people with type 2 diabetes (NewsRx, 2015).”

Participants

This study included 76 type II diabetes patients, 70% of which were male.  The average age of the participants was 67 years old.  These patients were newly diagnosed with Type II diabetes (NewsRx, 2015).

Intervention

“Patients were randomly assigned to either 30 minutes of exercise five days a week at 65 percent of their target heart rate or ten minutes of exercise three times a day, five days a week at 85 percent of their target heart rate(NewsRx, 2015).”

Duration

This article is said that the study showed benefits after 3 months duration.

Outcomes

Both high and low exercise showed decrease in hemoglobin levels.  It is noted that the shorter, more intense interventions showed an average 0.82 percent decrease in three-month blood sugar patterns compared with just 0.25 percent among lower intensity group (NewsRx, 2015).

Dietary patterns and management of type 2 diabetes: A systematic review of randomised clinical trials

The review summarized evidence from published studies on the effectiveness of low carbohydrate, macrobiotic, vegan, vegetarian, Mediterranean and intermittent fasting (IF) diets compared to low fat diets on diabetes control and management (Papamichou, 2019).

Participants

This review studied twenty randomized controlled trials lasting longer than 6 months that investigated the effectiveness of various dietary patterns on type 2 diabetes mellitus patients (Papamichou, 2019).

Intervention

Implementation of different diet patterns such as Mediterranean diet, DASH, low carbohydrate, macrobiotic, vegan, vegetarian, and intermittent fasting diet.

Outcomes

The study review showed that vegan, vegetarian and Mediterranean dietary patterns showed better glycemic control with type II diabetics (Papamichou, 2019).  “Four out of fifteen low carb diet interventions showed better glycemic control while weight loss was greater in one study (Papamichou, 2019).”

Literature Review Conclusion

With the studies reviewed, its clear that diet and exercise significantly impact blood glucose levels within type II diabetic patients.  Reviewed studies on exercise showed that exercise has an exponential impact on hemoglobin A1C levels.  The dietary reviews stated that further studies need to be conducted to rule out which diet intervention makes the most impact. The information gathered in the studies on diet and exercise in type II diabetes advocates for further research.  As a nursing student, I have learned that providing diabetes education to patients about both diet and exercise is essential.  The earlier the intervention after diagnosis, the greater the outcome of change.

Iowa Model of Evidence Based Practice

The model selected for this research proposal is the Iowa Model of Evidence-Based Practice.  This model helps introduce better patient outcomes by identifying problems, forming a leadership team, deliberate risks versus benefits, and performing research.   Nurses play an important role in the EBP and incorporate the Iowa Model of Evidence-Based Practice to enhance their practice.  Nurses are committed to make things better.

Implementing change in diabetes outcomes starts with the healthcare team and education.  Most of the diabetes education is done at the time of diagnosis.  It is here that the gap in diabetes management is created.  Healthcare providers should be incorporated on a multidimensional level to ensure the patient is fully aware of the impact of diabetes. This awareness does not come from just one visit with any healthcare provider.  The healthcare provider who initially makes the diagnosis of diabetes should incorporate referrals to other healthcare professionals.  This referral system should be a requirement of disease management.  This referral system requirement should be further researched to determine advantages and disadvantages.  Without the proper education and patient comprehension of diabetes, diet and exercise modifications are less likely to be implemented.

A barrier to diabetes management is patient compliance.  A patient may feel overwhelmed with the number of future visits needed and may not comply with the referral system.  Another barrier to making referral systems a required part of diabetes management, is financial constraints.  With health care costs on the rise, a patient may not have the proper health insurance coverage to meet the needs of proper diabetes management.  Institutions may also hold a financial barrier as well by not being able to schedule the needed amount of time with a patient, or there may not be enough diabetes educators.  Finding adequate funding is another barrier to diabetes research.

Funding

Finding appropriate funding and grants to support research expense are crucial.  Obtaining funding is a complex process as studies are costly (Gary et al. 2017).  With diabetes increasing in prevalence, there are many organizations that support diabetes research.  There are many steps required within the funding process.  These steps include finding applicable funding institutions, preparing a proposal, submission of proposal, award acceptance and compliance consideration, award set-up, monitoring finances, and close out.  When composing a research funding application there are many components to consider.

The key terms searched included “diabetes grant,” and “grant for diabetes,” both within the google database.  There are different institutions that offer funding for diabetes.  From those listed the biggest known funders found are the American Diabetes Association (ADA), National Institutes of Health (NIH), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).  When applying for any grant it is important to understand the application process.  Each research funding institution has its own application guidelines and should be followed according to their stated process.  It’s also beneficial to reach out to other professionals who are experienced in writing funding proposals in research.

Within the research funding proposal (RFP) document, it is essential that it addresses each detail within the requirements.   The document should include the problem, purpose, review of the current literature, framework, and outline of intended methods and procedures to conduct a study.  When creating the RFP, the researcher should consider the goals and outcomes of the study, benefits, risks, samples, etc. (Gray et at., 2017).  This information needs to be sufficient to essentially prove that one’s proposal is good enough to research. After completing an RFP, it should be reviewed, edited and revised.  With every submission of an RFP, a researcher should always be prepared for rejection.

Discussion and Conclusion

Diabetes is a chronic disease that is expected to affect around 592 million people by the year of 2035.  Diabetes management is multiplex and can be challenging to control.  Healthy lifestyle changes with diabetes are needed to control hemoglobin A1C levels.  With the future cases of diabetes projecting upwards, it’s important to continue research to better achieve disease management outcomes, and to also provide an emphasis on the importance of diabetes education.  To make diabetes more preventable and treatable, it’s important for healthcare professionals to educate any patient who has risk factors for diabetes.  This can provide a patient to be aware of what they may encounter if modifiable risk factors are not addressed.  The incidence of diabetes will continue to rise if these risks are not addressed with patients.

In relation to diabetes management, provided research suggests that individual nutrition therapy used concurrently with exercise will have the greatest effect on hemoglobin AIC.  Shorter more intense exercise in diabetics showed to have a higher impact on A1C levels.  Dietary patterns including vegan, vegetarian and Mediterranean revealed better glycemic control.   Based on the research findings, it is determined that the best management of diabetes is a combined effort of both exercise and dietary therapy to reducing hemoglobin AIC within one year.

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