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Table 2 Methods, design, and quality of studies for diet and physical activity in the treatment of pediatric type 2 diabetes mellitus.

From: In search of quality evidence for lifestyle management and glycemic control in children and adolescents with type 2 diabetes: A systematic review

Study Authors Primary Objective(s) Methods Results Authors' Conclusions
Willi et al., 2004 (29) To examine "the use of a ketogenic, very-low-calorie diet (VLCD) in the treatment of type 2 diabetes" Retrospective case-control study, in a sample of 20 morbidly obese (body mass index (BMI) > 30 kg/m2) youth (14.5 ± 0.4 years old) with T2D. A control group (n = 15), matched by age, race, gender, BMI, T2D duration, HbA1c and pharmacotherapy who attended a hospital-based, outpatient pediatric diabetes clinic were included. Participants who adhered to the VLCD for > 6 weeks (n = 15), had a 16% reduction in HbA1c (8.8 ± 0.6 to 7.4 ± 0.6, p < 0.005) after 8 weeks; adherence (total days) was associated with a greater reduction in HbA1c (r = -0.57, p < 0.01). In this same group, a reduction in BMI (43.5 ± 1.8 kg/m2 to 39.3 ± 1.7 kg/m2, p < 0.0001) was observed after 8 weeks. At two years follow-up, glycemic control had returned to baseline in the VLCD group. Among those who consumed the VLCD diet for > 6 weeks (number not specified), BMI was significantly lower compared to baseline values within the treatment vs. control group (absolute HgbA1c values and statistical comparison data not provided). A sustained improvement in BMI in the VLCD group at 2 years follow-up compared to baseline assessment (41.2 ± 2.1 vs. 44.2 ± 2.3 vs. 41.2 ±21. kg/m2, p < 0.05) and compared to the control group, who had a 3.7% increase in BMI from baseline. "The ketogenic VLCD is an effective short-term, and possibly long-term, therapy for pediatric patients with type 2 diabetes". (QI score = 8 or poor)
  1. Quality index based on Downs and Black (19) for the assessment of the methodological quality of randomized and nonrandomized studies of health interventions;
  2. VLCD - Very Low Carbohydrate Diet; BMI - Body Mass Index; HgbA1c - glycated hemoglobin; kcal - kilocalories