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ETHICAL ISSUES IN RESEARCH

Research Manuscript

Krystal Kirkland

Walden University

March 25th, 2012

Description of the issue

  • According to the American Diabetes Association (2012), there are 25.8 million people in the United States, or 8.3% of the population, living with diabetes. It is the seventh leading cause of death. (CDC, 2011)Arising from the body’s inability to produce insulin or use the insulin it produces, the body cannot convert sugars and starches into the energy required to fuel the body’s cells. Therefore, persons with unmanaged or uncontrolled diabetes can suffer (CDC, 2011) “[…] damage to the blood vessels, eyes, kidneys, heart, and nerves [as a result of excess sugar in the blood.]” Since the American Diabetes Association (2012) states that the undiagnosed cases in the United States may account for 25% of Americans, diabetesprevention, detection and management is of primary concern.
  • Moreover, several types of diabetes exist. Although they share the body’s inability to convert starches (carbohydrates) and sugars, the ways in which they develop, affect the body and engender other conditions differ (CDC, 2011). Type 1 diabetes (CDC, 2011), for example, is characterized by the body’s inability to produce insulin or its inability to produce enough insulin to convert the sugars and starches for vital physiological processes and energy. Arising during childhood or adolescence, this type of diabetes, formerly known as juvenile diabetes affects only 5% of all persons in the U.S. living with diabetes (American Diabetes Association, 2012).
  • Type 2 diabetes, the most common form in the United States, disparately affects African Americans, Latinos, Native Americans, Asian Americans, Native Hawaiians and other Pacific Islanders as well as the aged population over 45 years of age (American Diabetes Association, 2012; CDC, 2011). Type 2 diabetes results from the body’s inability to produce enough insulin for sugar and starch conversion and/or the body’s inability to use the insulin produced simply because it “ignores” the insulin itself (American Diabetes Association, 2012). Highly preventable yet prevalent due to lifestyle changes, Type 2 diabetes in American society merits concern and attention.
  • Gestational diabetes, on the other hand, arises during pregnancy. In fact, the CDC (2011) reveals that two to ten pregnant women in the U.S. out of every 100 will be diagnosed with gestational diabetes. Although gestational diabetes typically disappears after pregnancy, its perpetuation is classified as Type 2 diabetes. Some women diagnosed with gestational diabetes will also develop Type 2 diabetes later. Nevertheless (CDC, 2011), gestational diabetes can induce numerous complications including preeclampsia, preterm birth and C-section delivery.

Purpose of the study

The purpose of the study is to determine how race, gender, income and associative lifestyle factors may engender Type 2 diabetes, diabetes mellitus (DM). By assessing these factors, discerning the relationship between them, health promotion and health intervention programs can be developed to more effectively reduce the incidence of Type 2 diabetes, its severity and complications as well as the financial or economic burden of diabetes mellitus (DM). This, in turn, improves the quality of life for individuals with DM and those at risk for such (Healthy People.gov, 2012).Since the Department of Health (2006) contends that DM may become one of the largest health threats in the 21st century, Public Health agencies need to direct and implement more effective campaigns to reverse the growing number of DM cases and prevent them in the first place. Therefore, this research will inform such actions and initiatives.

Significance of the study

Although there is no known cure for diabetes, scientists claim to be closer to finding one. The American Diabetes Association is the nation's leading nonprofit health organization, one that works by providing diabetes information, research, and advocacy. Moreover, the Healthy People 2020 objectives, interventions and goals also intersect those of the American Diabetes Association. Since diabetes can lessen lifespan by as much as 15 years, the significance of this study may prove beneficial for the associative education, advocacy and prevention initiatives and reverse the alarming diabetes trend.

References

American Diabetes Association. (2010). Asystematic approach for program adaptation using

intervention mapping. Retrieved from

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(2012). Type 1. Retrieved from

(2012). Type 2. Retrieved from

CDC (2008). Diabetes, ages 20+. US, 1988-2008 (Source NHANES) data set. Health Data Interactive.

Retrieved from

Center of Disease Control and Prevention [CDC] (2011 Nov. 7). Diabetes & pregnancy.

Retrieved from

FHI (2004). Part 1: The how-to’s of monitoring and evaluation: Evaluation designs to assess

program impact. Retrieved from
4u3r6tqwz5uhx4ga7weqdisdru3opxers77zer56lniwg7jiaydjrcijv6vhv4mk/Chapter5.pdf

HealthyPeople.gov (2012) Diabetes. U.S. Department of Health & Human Services. Retrieved from

Issel, L. M. (2009). Health program planning and evaluation: A practical and systematic

approach for community health. Sudbury, Mass: Jones and Bartlett Publishers.

U.S. Department of Health (2006).

Gestational Diabetes and Diabetes Mellitus Continuum Literature Review

Krystal Kirkland

PUBH 6155

October 19, 2018

Dr. Lewis

Gestational Diabetes and Diabetes Mellitus Continuum Literature Review

Type 2 diabetes, also known as diabetes mellitus (DM) has captivated the attention of public health agencies and organizations. It has also merited concerted actions towards it management, early detection and prevention, as evidenced by its inclusion in the Healthy People 2020 public health campaign. While DM has some genetic basis, disparately affecting minority peoples, its correlation with gestational diabetes has also inspired investigation. Accordingly, studies have explored the connection between pre-pregnancy states and the incidence of gestational diabetes, effective and natural ways to mitigate and moderate gestational diabetes to prevent negative health outcomes for the mother and the infant and lifestyle interventions for women who experienced gestational diabetes. The latter of these has effectively demonstrated lesser incidence of subsequent DM development.

Nevertheless, most of the pieces of the puzzle are scattered across continents in various contexts and languages in growing bodies of research. The following literature review explores these studies seeking clues to and associative measures, direct attention toward due to its rising prevalence in the last two decades.

Discerning Risk

Discerning which factors contribute to the development of gestational diabetes and the subsequent increased risk of Type 2 diabetes, has informed the research questions for several studies. Because most nations seek cost-effective means to deliver quality and seek ways to exclude persons from unnecessary testing and procedures, finding more cost-effective and efficient means to diagnose and/or prevent conditions is paramount. However, determining how nations may do is much more difficult. After all, the 2002 literature review conducted by Kim, Newton & Knopp (2002) illustrated the wide variance 2.6% to over 70% in cases of gestational diabetes and associative risk for Type 2 diabetes.

Because the scope of their literature review covered two decades, the statistical representations may vary due to the emergence of knowledge, recognition of gestational diabetes and the standards of care requiring testing (Kim, Newton & Knopp , 2002). Nevertheless, the conclusions drawn by Kim, Newton & Knopp (2002) through their research showed that women with elevated fasting glucose levels during pregnancy might in fact prove to be the target group for prevention efforts. Notably, this includes those without gestational diabetes.

Treatment and Diagnostic Controversies

Therefore, Kim, Newton & Knopp (2002) contrast previous studies, inconsistent diagnostic criteria, and varied incidence in light of the controversy over treating gestational diabetes. To this end, Karagiannis, Bekiari, Manolopoulos, Paletas & Tsapas (2010) supported the Kim, Newton and Knopp (2002) recommendations. In fact, the Karagiannis, et.al., 2010 study demonstrated the clinical significance or treating maternal hyperglycemia. As evidenced by the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study, maternal glucose levels and adverse pregnancy outcomes are positively correlated across the continuum.

This finding was also substantiated by Anderberg, Kallen and Berntorp (2010). In fact, Anderberg, Kallen and Berntorp (2010) determined that even limited degrees of maternal hyperglycemia may affect the outcome of pregnancy. Their 2010 prospective observational cohort study of glucose tolerance levels also illustrated the correlation. However, their 2010 cohort study engaging glucose tolerance levels during pregnancy alternately suggested that GDM and low glucose tolerance increased associative risks but not as much as previously considered.

Moreover, the 2010 cohort study conducted by Anderberg, Kallen and Berntorp (2010) elucidated how hypertensive disorders during pregnancy, induction of labor and emergency cesarean section were not always positively correlated with gestational diabetes. Therefore, the associative outcomes once considered intrinsically tied to gestational diabetes can be explained through other conditions.

This, too, merits attention and leads to the interventions studied by Luoto, et.al. (2011) relative to infant birth weight, maternal weight gain and the need for insulin during pregnancy. Hypothesizing that lifestyle interventions could prove effective and beneficial, Luoto, et.al. (2011) used diet and physical activity counseling as the experimental intervention. Since high birth weights and the associative risks and complications are related to gestational diabetes and maternal weight gain, lifestyle counseling seemed appropriate. However, the findings showed that such interventions only affected infant birth weight, not gestational diabetes.

While it is impossible to know how controlled the conditions were during the study, it is suffice to say that self-monitoring has its own limitations. Nonetheless, the results, controlling infant birth weight through such lifestyle intervention counseling might prevent type 2 diabetes in children. It might also prevent post-partum development of type 2 diabetes. Therefore, it merits further consideration.

Interrupting the Continuum

Given the correlation between gestational diabetes, negative outcomes for the mother and the children and increased risk of Type 2 diabetes, Behrashi, Mahidan & Aliiasghara (2011) explored ways in which insulin requirements for women diagnosed with gestational diabetes could be modulated. Hypothesizing that women diagnosed with gestational diabetes mellitus from the 32nd week of pregnancy could be less insulin dependent if 35mg doses of zinc sulfate were prescribed, Behrashi, Mahidan & Aliiasghara (2011) used an RCT design. Women in the experimental group were given the 25mg of zinc sulfate orally once daily and the control group received insulin.

Their results demonstrated lesser incidence of infants with high birth weights. This could lessen type 2 diabetes risk for these infants. However, the Behrasi, Mahidan & Aliasghara (20110 also elucidated how zinc supplementation in gestational diabetes could reduce insulin needs and improve glycemic control of these patients. It might also reduce macrosomia.

These findings are important, given the Public Health focus on prevention. By moderating gestational diabetes and insulin dependence through oral doses of zinc sulfate, the continuum between gestational diabetes and type 2 diabetes is mitigated and moderated for infants. By decreasing birth weight, this lessens chances of later development. However, it might also prove beneficial for women with gestational diabetes. A post-partum cohort study might elucidate how zinc sulfate treatment might somehow encourage physiological adaptation and lessen the risk of Type 2 diabetes. If this were true, it could prove critical. It would also coauthor standards of practice and intervention and do so in ways that more women might accept throughout the world. After all, the World Health Organization (as cited by Mokaila, 2001) reveals that less than 20% of the world uses western medicine. Moreover, many women worry about insulin dependency during pregnancy.

Post-partum Type 2 Diabetes Risk and Intervention

As evidenced through the preceding studies, statistics relative to incidence of gestational diabetes and Type 2 diabetes vary widely. As previously stated, the 2002 literature review conducted by Kim, Newton & Knopp (2002) illustrated the wide variance 2.6% to over 70% in cases of gestational diabetes and associative risk for Type 2 diabetes. To examine the associative risk, the relationship between the two and gain better insight relative to lifestyle or other predisposing factors, several studies were conducted.

The 2010 Chittleborough, et.al. study of the gestational diabetes registry at one hospital in Australia conducted annual screenings for the women diagnosed with gestational diabetes. By sending out cards annually to these women and studying the results of their annual Type 2 diabetes screenings, the Chittleborough, et.al. (2010) study detailed how this resulted in early detection. Hypothesizing that early detection would promote better management and reduce diabetes related complication, the Chittleborough, et.al. (2010) study contended that such screenings could reduce costs. However, it did not try to determine the actual correlation, rate and incidence and/or any other contributing factors. Rather, it elucidated how annual post-partum screening could prove beneficial for women previously diagnosed with gestational diabetes.

For this reason, the Tuomilehto, et.al. 2001 randomized clinical trial is particularly important. Recruiting women 40 to 65 years of age with impaired glucose, it explored how lifestyle intervention could prevent diabetes (Tuomilehto, et.al, 2001). Over the course of three years, researchers conducted complete health assessments annually, measured height and weight and conducted an oral glucose test during those assessments (Tuomilehto, et.al, 2001). Individualized counseling pertaining to weight reduction, dietary habits, and physical activity served as the intervention for the experimental group (Tuomilehto, et.al, 2001).

The Tuomilehto, et.al. (2001) results demonstrated that diabetes could be prevented through lifestyle interventions despite impaired glucose. As evidenced by the measurements, the experimental group experienced (Tuomilehto, et.al., 2001) “11% incidence diabetes and 8.5±5.5 kg cumulative weight loss in control group after four years.” The control group diabetes incidence was 23% (Tuomilehto, et.al., 2001). Given the data, lifestyle interventions such as individualized counseling relative to diet, weight loss and physical activity could reduce diabetes incidence among the glucose impaired population in half. Accordingly, one in every two cases could be prevented.

This is particularly important given the rising incidence of diabetes mellitus. Even in the case of gestational diabetes in which the strength of the continuum between gestational diabetes and subsequent diabetes mellitus is relatively uncertain, lifestyle counseling and annual screenings might prove beneficial for at least the first five years. After all, the Retnakara, Austin & Shah (2005) population-based study proved that the linkage between gestational diabetes and diabetes mellitus diagnoses significantly weaken after 4.5 years. Even among women with subsequent pregnancies, the rates of gestational diabetes and diabetes mellitus were far less than previously considered. Accordingly, Retnakara, Austin & Shah (2005) determined the risks and the strengths of those risks and relationships are not as fixed as researchers previously thought. Rather, other contributing factors play roles in the prevention of gestational diabetes, subsequent diabetes mellitus development and the continuum itself.

With these findings, Kim, Newton & Knopp (2002) agreed. Their findings also suggested the continuum between gestational diabetes and diabetes mellitus also weakens significantly five years post-partum. Whereas, high fasting glucose levels during pregnancy may serve as the predictors, Kim, Newton & Knopp (2002) also contended many contributing factors strengthen the linkage between the two or extinguish it. For these reasons, studies must more definitely discover and detail these factors.

More Targeted Testing, More Predictive Factors

Focusing on the epidemiology of both gestational diabetes and diabetes mellitus, Ben-Haroush, Yogev & Hod (2003) conducted and extensive literature review. Seeking to establish the correlation between polycystic ovary disease (PCOS), pre-diabetic states and gestational diabetes mellitus, Ben-Haroush, Yogev & Hod (2003) discovered a linkage between them. In fact, PCOS diagnosis and pre-diabetic states informed the rates of gestational diabetes. Conversely, gestational diabetes informed subsequent PCOS diagnoses. Based upon these results, Ben-Haroush, Yogev & Hod (2003) suggested that this epidemiological finding verified through numerous studies could lessen the need for gestational diabetes testing and cut costs. Moreover, it could inform the need for subsequent testing relative to PCOS in women with gestational diabetes.

Conclusion

Based upon these studies and findings, the correlation and continuum between gestational diabetes and Type 2 diabetes, diabetes mellitus, is not as fixed as it was thought to be. While linkage does exist, other contributing factors and indicator may effectively refine and more clearly demarcate the correlative risk ratios. As demonstrated through the literature review, however, numerous aspects merit further study. Whereas the five year post-partum line between gestational diabetes and subsequent diabetes mellitus diagnosis, the five year window might prove beneficial for lifestyle interventions and prevention. It most certainly serves as the critical window in which associative risk is high.

Even though the reasons why are not fully understood, interventions commencing with gestational diabetes and continuing throughout that five-year critical window could prove the least costly and most effective. Notably, these would include nutritional and weight loss counseling, physical activity counseling, and the daily dose of 25 mg zinc sulfate orally during the 32nd week of pregnancy until delivery and annual glucose tolerance tests for five years post-partum. If this were implemented, the rates of subsequent diabetes mellitus diagnoses could be dramatically reduced (approximately halved). The cost-benefits for the mother alone would prove cost-efficient and prudent.

References

Anderberg, E., Kallen, K., & Berntorp, K. (2010). The impact of gestational diabetes mellitus on pregnancy outcome comparing different cut-off criteria for abnormal glucose tolerance. Acta Obstetricia Et Gynecologica Scandinavica, 89(12), 1532-1537. doi:10.3109/00016349.2010.526186