A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes.

BACKGROUND: In the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. SUBJECTS: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27-45 kg m(-2); age, 40-75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel. RESULTS: A significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (-11.27% (95% confidence interval (CI): -10.17; -12.36)) compared with the control group (-5.88% (95% CI: -3.79; -7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI: 2.56; 7.61) and body weight (95% CI: 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI: -1.52; -33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl(-1) and <100 mg dl(-1), respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol(-1))) at 6 months. CONCLUSIONS: Both the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow-up in real-world conditions. The Ma-Pi diet resulted in greater improvement in glycemic control.

Ma-Pi 2 macrobiotic diet and type 2 diabetes mellitus: pooled analysis of short-term intervention studies.

The macrobiotic, Ma-Pi 2 diet (12% protein, 18% fat and 70% carbohydrate), has shown benefit in adults with type 2 diabetes mellitus (T2DM). This pooled analysis aims to confirm results from four, 21-day intervention studies with the Ma-Pi 2 diet, carried out in Cuba, China, Ghana and Italy. Baseline and end of study biochemical, body composition and blood pressure data, were compared using multivariate statistical methods and assessment of the Cohen effect size (d). Results showed that all measured indicators demonstrated significant changes (p < 0.001); most of them with a very high (d ≥ 1.30), or high (d = 0.80-1.29) effect size. The global effect size of the diet was Italy (1.96), China (1.79), Cuba (1.38) and Ghana (0.98). The magnitude of the individual effect on each variable by country, and the global effect by country, was independent of the sample size (p > 0.05). Similarly, glycemia and glycemic profiles in all four studies were independent of the sample size (p = 0.237). The Ma-Pi diet 2 significantly reduced glycemia, serum lipids, uremia and cardiovascular risk in adults with T2DM. These results suggest that the Ma-Pi 2 diet could be a valid alternative treatment for patients with T2DM and point to the need for further clinical studies. Mechanisms related to its benefits as a functional diet are discussed.

Niveles séricos de leptina y su relación con la excreción de sodio en niños y adolescentes obesos / Relationship between serum leptin levels and sodium excretion in a local population of obese children and adolescents

La obesidad se asocia con niveles elevados de leptina y la mayoría de los individuos obesos presentan resistencia "selectiva" a su acción metabólica sin disminución del apetito ni aumento en el gasto energético, con preservación y estimulación de la activación del sistema simpático a nivel central y de las acciones periféricas cardiovasculares y renales. Estos mecanismos podrían modificar la regulación del metabolismo del sodio a nivel renal. Objetivo: identificar el comportamiento de los niveles séricos de leptina en asociación a la excreción urinaria de sodio en una población de niños y adolescentes obesos. Material y métodos: se estudiaron 190 niños y adolescentes entre 5 y 15 años: 125 con índice de masa corporal (IMC) percentilo = 95 constituyeron el grupo de obesos (OB) y 65 con IMC percentilo 5 - < 85 el grupo control (C). Las concentraciones de sodio sérico (Nas) y urinario (Nao) se midieron por electrodo ión selectivo; los niveles séricos de leptina por método radioinmunométrico. Resultados: se encontraron diferencias significativamente menores en los valores de sodio urinario (mEq/ kg/día) de la población obesa respecto a los controles, para ambos sexos en los distintos grupos etarios y se observó que los obesos presentan mayores valores de leptina/IMC (ng/ml/IMC) para menores concentraciones de sodio urinario en los diversos grupos/subgrupos: nenas OB 5 a 9 años: Nao 2,69 ± 0,19, leptina/IMC 0,63 ± 0,06; nenas OB 10 a 15 años: Nao 2,20 ± 0,17,leptina/IMC 1,11± 0,12; nenes OB 5 a 9 años: Nao 2,07± 0,16, leptina/IMC 0,80 ± 0,15; nenes OB 10 a 15 años: Nao 2,57 ± 0,23, leptina/IMC 0,65 ± 0,09. Nuestros resultados sugieren que los niveles séricos de leptina elevados, típicos de estados como la obesidad, podrían contribuir a las alteraciones en el metabolismo del sodio, dada la disminución de la excreción urinaria de dicho ión.

Obesity is associated with elevated levels of leptin and most obese individuals are "selectively" resistant to its metabolic action, without appetite loss or increased energy expenditure, with preservation and stimulation of the activation of the sympathetic system at both the central and peripheral cardiovascular and renal levels. These mechanisms could modify the regulation of sodium metabolism in the kidney. Objective: To determine whether there is any correlation among between serum leptin levels and urinary sodium excretion in a population of obese children and adolescents an obese, children and adolescents. Material and methods: 190 children and adolescents between 5 and 15 years of age were studied: 125 with body mass index (BMI) = 95 percentile constituted the obese group (OB) and 65 with BMI percentile 5 - < 85 the control group (C). Concentrations of serum sodium (Na) and urinary sodium (Nao) were measured with ion selective electrode; serum leptin levels were measured by the immunoradiometric method. Results: Differences between groups were significantly lower for urinary sodium values (mEq/kg/day) in obese subjects compared with controls for both sexes and in different age groups. The obese population has higher leptin/BMI (ng/ml/IMC) and lower concentrations of urinary sodium in the different groups/subgroups: OB girls 5 to 9 years of age Nao 2.69 ± 0.19, leptin/BMI 0.63 ± 0.06; OB girls 10 to 15 years Nao 2.20 ± 0.17, leptin/BMI 1.11± 0.12; OB boys 5 to 9 years Nao 2.07± 0.16, leptin/BMI 0.80 ± 0.15; OB boys 10 to 15 years Nao 2.57 ± 0.23, leptin/BMI 0.65 ± 0.09. Our study suggest that elevated serum leptin levels, typical of conditions such as obesity, may contribute to alterations in sodium metabolism, due to decreased urinary excretion of this ion.