Original Article

Citation: Nutrition & Diabetes (2016) 6, e230; doi:10.1038/nutd.2016.36
Published online 19 September 2016

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

A Goday1,2,3, D Bellido4, I Sajoux5, A B Crujeiras6,7, B Burguera8,9, P P García-Luna10, A Oleaga11, B Moreno12 and F F Casanueva6,7

  1. 1Department of Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain
  2. 2Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain
  3. 3CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain
  4. 4Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol and Coruña University, Ferrol, Spain
  5. 5Medical Department, Pronokal Group, Barcelona, Spain
  6. 6Division of Endocrinology, Department of Medicine, Complejo Hospitalario Universitario de Santiago (CHUS) and Santiago de Compostela University (USC), Santiago de Compostela, Spain
  7. 7CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain
  8. 8Endocrinology and Nutrition Department, Hospital Universitario Son Espases, Mallorca, Spain
  9. 9CAIBER-Investigation Unit, Hospital Universitario Son Espases, Mallorca, Spain
  10. 10Clinical Nutrition and Morbid Obesity Unit. Hospital Universitario Virgen del Rocio, Sevilla, Spain
  11. 11Endocrinology Department, Basurto Hospital, Bilbao, Spain
  12. 12Endocrinology and Nutrition Division, Hospital Universitario Gregorio Marañon, Madrid, Spain

Correspondence: Dr A Goday, Department de Endocrinología y Nutrición, Hospital del Mar. Passeig Marítim de la Barceloneta, 25-29, Barcelona 08003, Spain. E-mail: AGoday@parcdesalutmar.cat; Professor FF Casanueva, Division of Endocrinology, Department of Medicine, Complejo Hospitalario Universitario de Santiago (CHUS), Choupana street s.n, Santiago de Compostela 15706, Spain. E-mail: endocrine@usc.es

Received 25 April 2016; Revised 21 June 2016; Accepted 14 July 2016





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.



Evaluating the short-term safety and tolerability of a VLCK diet (<50g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM.



Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35kgm2 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.



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.



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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