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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  • dc.contributor.author Goday Arno, Albertoca
  • dc.contributor.author Bellido, Diegoca
  • dc.contributor.author Sajoux, Ignacioca
  • dc.contributor.author Crujeiras, Ana B.ca
  • dc.contributor.author Burguera, B.ca
  • dc.contributor.author García-Luna, Pedro Pabloca
  • dc.contributor.author Oleaga, A.ca
  • dc.contributor.author Moreno, B.ca
  • dc.contributor.author Casanueva, Felipe F.ca
  • dc.date.accessioned 2016-12-16T07:32:13Z
  • dc.date.available 2016-12-16T07:32:13Z
  • dc.date.issued 2016
  • dc.description.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.ca
  • dc.description.sponsorship The founding for the study as well as the DiaproKal Method products were provided by Pronokal Group., (Barcelona, Spain) free of charge to the patients. The funding source had no involvement in the study design, recruitment of patients, study interventions, the data collection or interpretation of the results.
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Goday A, Bellido D, Sajoux I, Crujeiras AB, Burguera B, García-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(9):e230. doi: 10.1038/nutd.2016.36ca
  • dc.identifier.doi http://dx.doi.org/10.1038/nutd.2016.36
  • dc.identifier.issn 2044-4052
  • dc.identifier.uri http://hdl.handle.net/10230/27780
  • dc.language.iso engca
  • dc.publisher Nature Publishing Groupca
  • dc.relation.ispartof Nutrition & Diabetes. 2016 Sep 19;6(9):e230
  • dc.rights © 2016 The Author(s)/nThis work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri https://creativecommons.org/licenses/by/4.0/ca
  • dc.subject.other Diabetisca
  • dc.subject.other Dieta per a malaltsca
  • dc.title 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.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

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