Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/12283
Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus
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DOI: 10.1038/nutd.2016.36
ISSN: 2044-4052
WOS ID: 000391954900002
Scopus EID: 2-s2.0-84988428098
PMID: 27643725
Embase PUI: L612236825
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2016-09-19Document type
research articleCitation
Goday A, Bellido D, Sajoux I, Crujeiras AB, Burguera B, Garcia-Luna PP, et al. Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Nutr Diabetes. 2016 Sep 19;6:e230.Abstract
BRACKGROUND: The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. OBJECTIVE: Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. METHODS: Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet. RESULTS: No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. CONCLUSIONS: The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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https://dx.doi.org/10.1038/nutd.2016.36MeSH
Diabetes Mellitus, Type 2Aged
Blood Glucose
Adult
Diet, Reducing
Humans
Life Style
Behavior Therapy
Middle Aged
Glycated Hemoglobin A
Weight Reduction Programs
Male
Prospective Studies
Female
Treatment Outcome
Weight Loss
Caloric Restriction
Diet, Ketogenic
Waist Circumference
DeCS
Pérdida de PesoResultado del Tratamiento
Femenino
Hemoglobina A Glucada
Masculino
Restricción Calórica
Circunferencia de la Cintura
Dieta Cetogénica
Humanos
Persona de Mediana Edad
Programas de Reducción de Peso
Glucemia
Dieta Reductora
Estudios Prospectivos
Terapia Conductista
Estilo de Vida
Anciano
Diabetes Mellitus Tipo 2
Adulto