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Effects of Nutritional Recommendations on Metabolic Control in Individuals with Type 2 Diabetes: A Systematic… Bridge, Candice; Dunderdale, Sarah; Sarsfeld, Jocelyn; Skopac, Robyn; Tozer, Jamey 2009-07

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 È T2D is a metabolic disorder indicated by the presence of hyperglycemia as a result of insulin insensitivity i 3 million Canadians with diabetes, 246 million people worldwide o 2025 an estimated 380 million individuals worldwide will have diabetes › 90% of those have T2D e $20 billion/year by 2020 Definition G HbA1c: › used as a marker for the amount of glucose in plasma › this reaction is irreversible therefore a stable marker to measure glucose values › best indicator of glycemic control o 2   complications: › heart disease › kidney disease › stroke › blindness › erectile dysfunction › leg amputation › ↓ QoL › premature death Œ Onset of T2D may be delayed or prevented with a healthy lifestyle › physical activity, healthy diet & weight y 80% of individuals with T2D are overweight or obese l 3-7x greater prevalence T2D in obese adults v Fatty tissue ↑ insulin resistance ¬ Obesity is a critical modifiable risk factor for T2D & recent evidence suggests weight management to be the most important therapy r Diet & weight lifestyle modifications require goal setting & pt centered care with follow up t Weight loss of 5-10% = improved glycemic control & ↓ associated risk factors by ↓ lipid levels & BP È Nutrition therapy alone can improve glycemic control by1-2% y HbA1C levels should be < 7% e > 7.5% ↑ risk of micro & macro vascular complications ie. retinopathy & CV disease . Clinically significant change in HbA1C: › HbA1C of 6- 7.5% or › 10% ↓ from baseline in the first 4-6 wks ¬ A well supported nutritional regimen can effect positive change in metabolic parameters; however, there is little research on effects of nutritional advice provided by HCPs b Weight loss with a well-balanced nutritional regimen can cure T2D & ↓ premature mortality  Dieticians & nutritionists have specialized knowledge in prescribing nutritional plans; this needs to be supported & reinforced by other HCPs such as PTs Ì CDA does not yet recognize PTs as members of a diabetic health care team c PTs are not recognized to be involved in reinforcing dietary recommendations patients who are obese d Dean (2009) has advocated a major role for PTs in effecting multiple health behavior change l Morris & colleagues (2009) have outlined how PTs can incorporate such assessment & recommendations into daily practice è PTs are primary HCPs that maximize function at the activity and participation levels of the ICF  Need for nutritional and dietary education groups integrated into PT management plan d This review will enhance the PTs’ comprehensive knowledge of T2D and awareness of healthcare providers 1. To examine the effectiveness of nutritional recommendations in improving metabolic control in people with T2D 2. To examine the role of physiotherapists in making nutritional recommendations that can be incorporated within the constraints of clinical practice ¬ Preliminary search: › CINAHL, MEDLINE, FSTA & EMBASE  grey literature search: › conference proceedings, theses & dissertations, government publications, clinical trials, reference lists of included articles , Terms and MeSh headings › P: diabetes mellitus, diabetes mellitus type 2, overweight, obesity › I: diet therapy, food habits, health promotion, health behavior, diabetic education, nutrition therapy, nutrition › O: weight loss, body weight changes, body weights and measures, BMI, waist to hip ratio, body mass, waist circumference or body composition › For further narrowing: dietetics, community health services, physical therapists, patient care team or allied health Inclusion criteria (1) aged 18 and older (2) T2D based on lab glucose test or physician diagnosis (3) measured : BMI, WHR and/or WC (4) RCT based on dietary intervention with minimum 1 session & six-month  follow up  Exclusion criteria (1) absence of a control group or active control group (2) the length of follow up < 6 months (3) the presence of cardiac conditions or renal disease (4) animals as test subjects (5) written in languages other than English È Initial screening › 2 people reviewed 598 titles d Study selection › standardized screening tool utilized › 3rd party consensus meeting where a consensus could not be met  n Quality Assessment: PEDro scale › Criterion was modified such that blinding subjects, participants and HCPs were not used to calculate the final score › Due to nature of the interventions blinding in these studies was not possible › Internal validity reduced from lack of blinding ¬ Data extraction › Comparison groups › Purpose of the study › Description of participants › Duration of study › Description of intervention & non- intervention groups › Primary/secondary outcome measures › Conclusions ˆ Study selection › 598 titles          ↓ 76 selected for abstract review               ↓           17 selected for full text review               ↓            4 articles met final criteria i Reasons for exclusion      i) active control groups were used            ii) studies were not RCTs             iii) anthropometric measures were not included ð Quality Assessment › mean methodological quality of the studies was 6.75±1.26 out of 8  Ranging between 5 – 8 › 3 high quality,1 moderate quality  Common flaws: lack of concealed allocation and inadequate number of participants for follow up r 1 study differed significantly at baseline for 1 primary outcome measure p Characteristics of participants › 1408 total: T 844 underwent nutritional interventions t 564 controls who continued basic medical care › 395 men & 449 women › Age: 55.43±2.84 yr (53-59) › HbA1c: 7.9 - 8.3%, average 8.15±0.19% › Weight: 91.8 - 107.1 kg, average 96.69±7.02 kg L Characteristics of Interventions › Duration T 3 studies of 12 months, 1 study of 6 months › Total time T with HCP 3–12 hrs, average 6.25±4.03 hrs h Franz et al., 1995 › BC: single visit with dietician › PGC: 3 visits with dietician, (1hr, 2 X 30-45min) t Davies, 2008 › 6 hrs of structured group education in community in 1 or 2 sessions by trained HCP  Wolf, 2004 › 6 individual & 6 small group sessions with dietician lasting 1 hr, brief monthly phone calls i Christian, 2008 › initial 10-minute computer Ax , 3 subsequent sessions with physician every 3 months Statistical significance i Wolf et al., (2004) reported a difference between control & intervention groups (p=0.02 Wolf) › greatest difference at 4 months (-0.57%, p=-.008) compared with 12 months (-0.20%, p=0.45)  Franz et al., (1995) reported a reduction from baseline to 6 months (p< 0.001) ) BC: -0.7% PGC: -0.9% › greatest ↓ in HbA1c for both intervention groups occurred between baseline & 6 wks, this reduction was maintained up to 3 months › From 3 - 6 months, HbA1c  ↑ Clinical Significance A reduction of 10% from baseline or an HbA1c  less than 7.5% is considered clinically significant c Only the PGC intervention group in Franz et al.,1995 achieved a clinically significant change in HbA1c › mean HbA1c 7.4% at 6 months s Davies et al., 2008 reported a clinically significant reduction in HbA1c in both control and intervention groups: ↓ to 6.7% & 6.8%, respectively › After adjusting for baseline and cluster effects results not sig (p=0.52) -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 2 4 6 8 10 12 14 HbA1c change (%) Glycemic Control change over intervention period. Franz Christan Wolf Davies Time (Months) 0 Wolf et al., 2004 reported a sig diff in mean weight change between groups › 4, 6 & 8 months p< 0.001, 12 months  p≤ 0.05 in intervention group › 8 months was greatest ↓ in weight in intervention group (-4.0 kg) & greatest net weight ↓ between groups (-5.0 kg) › 12 months control group gained 0.6 kg & intervention group lost 2.4 kg l Davies et al., 2008 reported sig diff between control & intervention groups at 4 & 12 months (p=0.024 and p=0.027) Control -1.86 kg Intervention -2.98 kg   (12 months) › Difference between groups not sig at 8 months; however, greatest weight loss for control & intervention groups at this time ¨ Franz et al., 1995 reported a sig weight loss from baseline to 6 months in both intervention groups › Weight reduction at 6 wks maintained at 6 months (p< 0.001) › BC & PGC groups lost 1.7 kg (p<0.01) and 1.4 kg (p<0.001) Clinical Significance A weight loss > 5% from the initial visit was considered clinically significant (CDA) f None of the studies included in this review had clinically significant findings  È Results of this study indicate nutritional therapy is a viable option s Even without clinically significant weight loss, glycemic control was positively influenced in individuals with T2D who were also obese with smaller, gradual amounts of weight loss  Support from health care providers is important for maintaining weight loss ì Physiotherapists are in a prime position to provide basic nutritional recommendations  To the best of our knowledge there is no entry level or post graduate training specific to PT a Eriksson et al, 2006 conducted a study utilizing PTs,  in an activity program & to support diet counselling to ↓ CV risk factors  found differences among weight, BMI, physical activity & other outcomes p Those with T2D for longer than 6 months achieved better results with more advanced dietary care r Optimally , nutritional recommendations can result in significant weight loss and effective metabolic control reducing or eliminating the need for pharmacological intervention Ð Metabolic control & weight loss tended to regress toward baseline values a Individuals who are obese and who have had T2D for some time require the same intensity if not more support from HCPs as T2D progresses p PTs have an important role in providing basic nutritional recommendations m Change can be implemented, supported, and sustained with brief interventions r Holistic practice & valuable, cost-effective method of providing ongoing nutritional support for individuals with T2D to maintain weight loss or continue weight loss to positively effect glycemic control ¬ The intensity and frequency of contact with HCPs appear to be key factors in metabolic control e There is no clear guideline for recommendations on frequency › There was a positive relationship between follow-up frequency and maintenance of change l Problematic methodological issues › Potential performance bias mInternal validity: lack of blinding assessors, patients, and health care providers › Basic care control groups were poorly defined › Not ethical to withhold care to create a ‘true’ control which minimizes the measured effects of the interventions l Variable effectiveness of a nutritional recommendations on individuals who are obese with T2D o Ongoing support is important for long term metabolic control l Basic care is insufficient for long term management of T2D 0 Thank you Dr. Elizabeth Dean for your wisdom and guidance throughout the past year o Dr. Darlene Reid for guidance in the early stages  Charlotte Beck for guidance with our search o Fellow classmates for general support and discussion over the year


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