Rising Type 2 Diabetes in Youth

Introduction

Background

There is an increase in Type 2 diabetes cases among the youth. In 2000, American Diabetes Association and American Academic of Paediatric acknowledged that T2DM is a pediatric disorder1. T2DM accounts for 90-95% of all cases of diabetes in the United States. According to an investigation carried, out of 8-45% are children and adolescent2’3. However the exact data of prevalence of T2DM in children and adolescent is lacking in Europe4. In Tanzania, the expenditure for diabetes was 2.5$ as estimated by WHO in 2005-20155. Type 2 diabetes is a global public heath challenge. In 2010 it was estimated that 285 million people have Diabetes, and the number will rise to 439 million by 20306. A 69% increase in the number of adults with Diabetes in developing countries and 29% in developed countries between 2010 and 2030. This assessment demonstrated increased burden of diabetes, especially in the third world countries. It indicated that without successful prevention and control projects, the prevalence will continue to rise worldwide6.Type 2 Diabetes is marked by insulin resistance with relative deficiency7. During puberty stage, there is peak time of insulin resistance8.Insulin resistance and beta cell dysfunction are underlying deficiency known to get going the onset of T2DM by numerous years. Failure of the beta cell begins 10 -12 years before the appearance of symptoms and signs of T2DM.This gives us chance to target these defects through primary prevention. T2DM is ongoing morbidity in adolescent and children, it is a forewarning which signifies the premature onset of cardiovascular diseases (CVD), microvascular retinopathy, neuropathy, and nephropathy, with the risk of decrease quality of life and untimely death9.Type 2 Diabetes is related to overweight, obesity, physical inactivity, low dietary fiber and high saturated fat intake.These are the modifiable risk factor for the development of T2DM in children and adolescent. The reason for an elevated number of T2DM is not known, however ,it is presumed that elevating a number of young people with T2DM represent the foreground obesity epidemic that is extending across the US, other developed countries and more currently in numerous countries around the world10. There is ethnicity consideration, whereby Polynesian, Micronesia, South Asian, and Sub -Saharan African, Arabian and Native American are more susceptible to develop diabetes than Europoids11. In prevention of T2DM in children and adolescent an intervention should be done in advance when blood glucose level are still normal or during the stage of impaired glucose tolerance (IGT)/impaired fasting glucose(IFG).Prevention of increase in weight/weight loss is considered as a foremost strategy in children and adolescent. This should be attained by lifestyle intervention comprising, decrease in sedentary behavior, dietary change and elevated physical activity12. The International Diabetes Federation (IDF) call for agreement in Lisbon Portugal in 2006 to address the burden of T2D and the needed of its prevention. IDF advocate plan for diabetes prevention based on controlling modifiable risk factor. The IDF targets physical activity by walking at least 30 minutes daily which decrease the risk of diabetes by 35%-4013.Randomized controlled trials including a combined physical activity and diet intervention revealed some assurance for school –based program to the obesity and hence prevention ofT2DM in children and adolescent14.

These Research will answer the question because primary prevention help to avoid or delay progression of the disease, the children and adolescent will understand what Diabetes is and how to avoid it. Therefore it has an important implication of avoiding the risk of disease complication at an early age of working and earning capacity15.

Literature review

Literature search

A structured literature review was initiated for evidence supporting the proposal question through searching MEDLINE, EMBASE, the Cochrane, and Web of Science database from1990 to present for English language articles. Researches were carried out by using the following keywords, alone and in combination. On insulin dependent diabetes mellitus, T2DM, primary, prevention, Search terms were combined by Boolean Logic or command using “AND” and “OR”. A total of 1896 publication were identified. However, only 15 contained prevention data on T2DM in school children, adolescent, and youth. In a total of 15, only 4 are school- based prevention of T2DM in school children and adolescents. The remaining articles addressed T2DM in adults.

The evidence for primary prevention of type 2 diabetes in school children and adolescent

The HEALTH trial which was school based on prevention of T2D in adolescent, cluster design randomized trial with a total of 4603 participants. 42 schools were involved with 21 prevention and 21 control. The outcome revealed that complete school- based project did not show a decrease in overweight and obesity16. On the other hand, a significant decrease in different indexes and adiposity were observed. They concluded that T2D could be prevented, however, the trial had limitation due to over sample in low income among black and Hispanic student, a sample was not nationally presented. On the other hand, the intervention was facilitated by staff and funds provided by the study, such an intended results could not examine the practicability, effectiveness and hence not supportable.16 BIENESTER trial school based T2DM prevention, cluster randomized control trial with a total of 2603 participant. 27 school included with 13 prevention and 14 control respectively. The prevention was done through Banister healthy and physical education, health club, family fiesta and food services. The outcome revealed that prevention group showed significantly lower glucose, elevate fitness and fiber intake than those in the comparison group. However, adiposity did not differ between the two groups17. Furthermore, School Acting in Leicester Against Diabetes SALAD and heart disease, a school-based project randomized controlled trial, which included 4763 children and adolescent aged 11 -15 of year 7-10 from inner city secondary school with the intervention of health diet, and increases physical activity. The study revealed that the school- based project for prevention was examined to be convenient but challenging. However, the study utilized the representative sample. On the other hand, there was a barrier to a healthy lifestyle in student included inadequacy motivation and the impact of factors such as cost and school resource limitation18. Looking for further insights on Applied Science for Health and Wellbeing? Click here.

The aims and objectives of pilot study

The primary objective is to assess whether the primary prevention reduces the risk to the development of Type 2 Diabetes in School Children and Adolescents. Primary prevention is the prevention which is done before the presence of symptom or signs of a particular disease.

Primary objectives

Fasting glucose mg/dl: Since development to pre- diabetes, and diabetes is related to increasing of fasting glucose level children-adolescent decrease in glucose level would demonstrate decreases the risk of progression to diabetes.

Fasting insulin: insulin resistance estimated by fasting hyperinsulinism, this is an early disorder in development to T2DM.Children –adolescent reduction in the average fasting insulin level would demonstrate the decrease in insulin resistant and risk for progression to T2DM. The risk of progressing T2D starts untimely in life, and primary prevention of T2D through interventions to reduce risk factors should start as early as possible. School children and adolescent represents the ideal time since children develop through puberty, a time known to increase adiposity and insulin resistance. Furthermore, decreases in average fasting glucose and insulin levels, as measures of dysglycemia and insulin resistance, in prevention and comparison group will be significant outcome indicators to evaluate if the prevention has a positive impact to- decrease the risk of T2DM.

Secondary objective

Body mass index of less than 25, BMI of equal or greater than 25 is related to diabetes.

To promote and contribute understanding of healthy behavior. A BMI greater than the 25kg/m2 was related with increased fasting glucose and insulin levels.

To develop ongoing healthy behavior Lifestyle modification can be attained by the change in behavior through an elevated quantity of physical activity and reduce sedentary behavior. Elevate intake of vegetable, fruits, and dietary fiber and reduce intake of high fat and sugar. Elevate intake of water and low- fat milk and reduce intake of added sugar beverage.

Justification of the proposal

The prevalence of T2DM is increasing in young adults. Prevention of diabetes in children and adolescent need altering a complex group of behavior model. Family and community participation is important for primary prevention projects in children because of their support for behavior change and continuing to strengthen the behavior modification. Furthermore, the approach should be culture thoughtful. Culture belief like obesity needs to be understood and addressed19. In addition, this age group not only represent a period of physical and metabolic progression but also mental growth and development. In the course of this period, children are taking more control of their own selections. Lifestyle modification through comprehensive intervention to adapt good health behavior can be done by P/A practice and health nutrition in young. This intervention reduces overweight and obesity, thus enhance insulin resistant and pre –diabetes and diabetes prevention. The behavior of adolescents are shaped more to their age group than parents, hence school setting will give a chance for good performance of P/A and health nutrition intake16. The outcome of evidence for primary prevention of T2DM in school children and adolescent are promising17. However, few cluster RCTs studies have been conducted, thus more studies are needed. On the other hand, the investigator will conduct Pilot RCTs, therefore the study will examine the feasibility of a strategy that planned to be utilized in a large cluster RCTs. The outcomes can be utilized to evaluate the feasibility of randomisation, recruitment, retention, assessment procedure and implementation of intervention for the large scale study.

Method

Study Design:

It will be Pilot Randomized Controlled Trial.The study is school based, the objective is to determine whether Primary Prevention for Type 2 Diabetes will reduce a risk of its development in School Children and Adolescence.The participants are children aged 10-15 years. A total of 4 School will blindly randomize for intervention and control arm. Two schools will be exhibit intervention and two schools will be control arm. The eligible criteria (Table-appendix1) are based on school and student. For the school to be in the trial must accept the randomization of school to be either intervention or control group.The school has a playground enough for physical education. The student will attend physical education class and extra class hour for classroom education to increase knowledge and empower decision-making skills and social influence. The school has to agree on supervision for group and behavior change to the student by removing sugar beverage from school shop and put more water, low- fat milk, and fruit. Failure of a school to agree on above criteria it will be excluded from the study. For the student to be eligible to continue with the study, student’s parent or guardian has to prove consent (Written in the Swahili language) that will show accepting the child to join the study and assessment procedure. Furthermore, each student has to provide informed consent showing that they understand the study and they were not forced to join the study in the data gathering and assessment procedure. The student should not be suffering from type one diabetes, heart disease, or have any medical problem that the study will cause harm to his or her healthy. The Intervention consists of four component with themes (Table2- appendix2) Physical activity; the P/A will be an aerobic exercise for 30 minutes, aerobic exercise help to control weight, makes heart and lungs strong. Examples of aerobic exercise are brisk walking, bike riding, jumping, rope, running and dancing. Diet to be followed; the diet will be low- calorie foods, vegetable, fruits, and more water intake. Behavioral knowledge and Skills. Including group and individual behavior change like increase water intake, choose healthy food, self-monitoring, goal setting, and problem- solving, decrease sedentary time. Recruitment of the study participant will be done by schoolteacher /class teacher and nurse from District hospital, food service staff. The investigator will provide to Principal a written summary for the requirement of a trial from schools as well as the advantage of the school, Teachers, parents, and student. They will also learn the importance of confidentiality and privacy of the person. Furthermore, the study confidentiality will be respected by given Identification number to the student.

Study Site: The study will be conducted at Kinondoni District in Dar es Salaam, Tanzania.

Target Population: All school Adolescent aged 10years -15years.

Study Population: The study population will include all School Children and Adolescence attending selected School at Kinondoni District from October 25th, 2016 to June 2017.

Sample Size: The sample size is determined by the number of schools (cluster) needed in every intervention group.In addition intercluster correlation coefficient (ICC) at 95% (CI) confidence interval.

Data Collection:

The measurement and observation of student will be made at school. The demographic and descriptive data (table2- Appendix 3) will be collected by a nurse, and a recruited teacher for the study. The measurements are: weight, height, waist circumference, blood pressure, blood for fasting glucose, fasting insulin and lipids. The weighing scale, laboratory equipment like pricker; glucometer will be used for data collection. The baseline data will be gathered at the beginning of the year January 2017 and concluding outcome data will be collected at the end of the study.

Data Analysis

The statistical analysis will be conducted by a statistician. The data will be gathered throughout the trials. The statistics will be presented in tabulation, plot ant graphs.

The primary outcome:

Fasting glucose reduction

Fasting insulin

The secondary outcome:

Weight reduction

Knowledge in diabetes prevention

Behavior change in P/A and nutrition.

Health and safety

Protection of children from risk related to the trial is concerned to study investigator. Thus appropriate protection for the study will be followed. A protocol will be approved by the ministry of education for environmental safety for the children.

Public and Patient involvement:

The Public patient involvement is very important in research. The investigator will request stakeholder to participate prior the start of the trial. Stakeholders will be involved as a funder, advocate, and co-researcher for advice and decision making like an assortment of participant20 Their support, and advice will facilitate the trial to achieve the aim. The Guidance for Reporting Involvement of Patient and Public(GRIPP) checklist will examine the quality of PPI report22.

Ethical consideration

The trial will involve children, parents, and school. Permission to conduct the research will be Obtained from District medical officer, District Ethical Commission office and Ministry of Education. The ethical principal have been considered in this pilot trial

Oral and written parental consent

Respect of child participation

Student written consent.

Appendix1

Table for inclusion and exclusion criteria

Appendix2

Intervention themes

Appendix 3

Data collection sheet.

References

.American Diabetes Association, 2000. Type 2 diabetes in children and adolescents. Pediatrics, 105(3), pp.671-680.

Rosenbloom AL. Increasing incidence of type 2 diabetes in children and adolescents. Pediatric Drugs. 2002 Apr 1;4(4):209-21.

American Diabetes Association, 2000. Type 2 diabetes in children and adolescents. American Diabetes Association. Diabetes care, 23(3), pp.381-389

Kiess W, Böttner A, Raile K, Kapellen T, Müller G, Galler A, et al, Type 2 diabetes mellitus in children and adolescents: a review from a European perspective. Hormone Research in Paediatrics. 2004 Nov 17;59(Suppl. 1):77-84.

Whiting DR, Guariguata L, Weil C, Shaw J. Author. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes research and clinical practice. 2011 Dec 31;94(3):311-21.

Mayer-Davis EJ. Type 2 diabetes in youth: epidemiology and current research toward prevention and treatment. Journal of the American Dietetic Association. 2008 Apr 30;108(4):S45-51.

Berry D, Urban A, Grey M. Understanding the development and prevention of type 2 diabetes in youth (part 1). Journal of Pediatric Health Care. 2006 Feb 28;20(1):3-10.

PARADIS G, LEVESQUE L, MACAULAY AC et al. Impact of a diabetes prevention program on body size, physical activity, and diet among kanien’keha:Ka (mohawk) children 6 to 11 years old: 8-year results from the Kahnawake schools diabetes prevention project. Pediatrics 2005: 115: 333–339.

Treviño RP, Yin Z, Hernandez A, Hale DE, Garcia OA, Mobley C. Impact of the Bienestar school-based diabetes mellitus prevention program on fasting capillary glucose levels: a randomized controlled trial. Archives of pediatrics & adolescent medicine. 2004 Sep 1;158(9):911-7.

18.Khunti K, Stone MA, Bankart J, Sinfield P, Pancholi A, Walker S, Talbot D, Farooqi A, Davies MJ. Primary prevention of type-2 diabetes and heart disease: action research in secondary schools serving an ethnically diverse UK population. Journal of Public Health. 2008 Mar 1;30(1):30-7.

Burnet D, Plaut A, Courtney R, Chin MH. A practical model for preventing type 2 diabetes in minority youth. The Diabetes Educator. 2002 Sep;28(5):779-95.

The GRIPP checklist. Ref: Sophie Staniszewska, Jo Brett, Carole Mockford, Rosemary Barber. Authors. Strengthening the quality of patient and public involvement reporting in research. International Journal of Technology Assessment in Health Care, 27:4 (2011), 391–39