PMID- 27643725
OWN - NLM
STAT- MEDLINE
DCOM- 20170905
LR  - 20221207
IS  - 2044-4052 (Electronic)
IS  - 2044-4052 (Linking)
VI  - 6
IP  - 9
DP  - 2016 Sep 19
TI  - 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.
PG  - e230
LID - 10.1038/nutd.2016.36 [doi]
AB  - 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.
FAU - Goday, A
AU  - Goday A
AD  - Department of Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.
AD  - Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain.
AD  - CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain.
FAU - Bellido, D
AU  - Bellido D
AD  - Division of Endocrinology, Complejo Hospitalario Universitario de Ferrol and 
      Coruna University, Ferrol, Spain.
FAU - Sajoux, I
AU  - Sajoux I
AD  - Medical Department, Pronokal Group, Barcelona, Spain.
FAU - Crujeiras, A B
AU  - Crujeiras AB
AD  - Division of Endocrinology, Department of Medicine, Complejo Hospitalario 
      Universitario de Santiago (CHUS) and Santiago de Compostela University (USC), 
      Santiago de Compostela, Spain.
AD  - CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain.
FAU - Burguera, B
AU  - Burguera B
AD  - Endocrinology and Nutrition Department, Hospital Universitario Son Espases, 
      Mallorca, Spain.
AD  - CAIBER-Investigation Unit, Hospital Universitario Son Espases, Mallorca, Spain.
FAU - Garcia-Luna, P P
AU  - Garcia-Luna PP
AD  - Clinical Nutrition and Morbid Obesity Unit. Hospital Universitario Virgen del 
      Rocio, Sevilla, Spain.
FAU - Oleaga, A
AU  - Oleaga A
AD  - Endocrinology Department, Basurto Hospital, Bilbao, Spain.
FAU - Moreno, B
AU  - Moreno B
AD  - Endocrinology and Nutrition Division, Hospital Universitario Gregorio Maranon, 
      Madrid, Spain.
FAU - Casanueva, F F
AU  - Casanueva FF
AD  - Division of Endocrinology, Department of Medicine, Complejo Hospitalario 
      Universitario de Santiago (CHUS) and Santiago de Compostela University (USC), 
      Santiago de Compostela, Spain.
AD  - CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn), Madrid, Spain.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160919
PL  - England
TA  - Nutr Diabetes
JT  - Nutrition & diabetes
JID - 101566341
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Behavior Therapy
MH  - Blood Glucose/analysis
MH  - *Caloric Restriction/adverse effects
MH  - Diabetes Mellitus, Type 2/*therapy
MH  - *Diet, Ketogenic/adverse effects
MH  - *Diet, Reducing/adverse effects
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Life Style
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Waist Circumference
MH  - Weight Loss
MH  - Weight Reduction Programs/*methods
PMC - PMC5048014
COIS- AG, DB, BM, ABC and FFC received advisory board fees and or research grants from 
      Pronokal Protein Supplies Spain.
EDAT- 2016/09/20 06:00
MHDA- 2017/09/07 06:00
PMCR- 2016/09/01
CRDT- 2016/09/20 06:00
PHST- 2016/04/25 00:00 [received]
PHST- 2016/06/21 00:00 [revised]
PHST- 2016/07/14 00:00 [accepted]
PHST- 2016/09/20 06:00 [entrez]
PHST- 2016/09/20 06:00 [pubmed]
PHST- 2017/09/07 06:00 [medline]
PHST- 2016/09/01 00:00 [pmc-release]
AID - nutd201636 [pii]
AID - 10.1038/nutd.2016.36 [doi]
PST - epublish
SO  - Nutr Diabetes. 2016 Sep 19;6(9):e230. doi: 10.1038/nutd.2016.36.