Abbasi J Interest in the Ketogenic Diet Grows for Weight Loss and Type 2 Diabetes. JAMA. 2018 Jan 16;319(3):215-217. doi: 10.1001/jama.2017.20639. No abstract available.
American Diabetes Association 5. Lifestyle Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S46-S60. doi: 10.2337/dc19-S005.
American Diabetes Association 8. Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S81-S89. doi: 10.2337/dc19-S008.
Baker ST, Jerums G, Prendergast LA, Panagiotopoulos S, Strauss BJ, Proietto J Less fat reduction per unit weight loss in type 2 diabetic compared with nondiabetic obese individuals completing a very-low-calorie diet program. Metabolism. 2012 Jun;61(6):873-82. doi: 10.1016/j.metabol.2011.10.017. Epub 2011 Dec 5.
Barengolts E GUT MICROBIOTA, PREBIOTICS, PROBIOTICS, AND SYNBIOTICS IN MANAGEMENT OF OBESITY AND PREDIABETES: REVIEW OF RANDOMIZED CONTROLLED TRIALS. Endocr Pract. 2016 Oct;22(10):1224-1234. doi: 10.4158/EP151157.RA. Epub 2016 Jul 13.
Caresio C, Salvi M, Molinari F, Meiburger KM, Minetto MA Fully Automated Muscle Ultrasound Analysis (MUSA): Robust and Accurate Muscle Thickness Measurement. Ultrasound Med Biol. 2017 Jan;43(1):195-205. doi: 10.1016/j.ultrasmedbio.2016.08.032. Epub 2016 Oct 6.
Cicero AF, Benelli M, Brancaleoni M, Dainelli G, Merlini D, Negri R Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study. High Blood Press Cardiovasc Prev. 2015 Dec;22(4):389-94. doi: 10.1007/s40292-015-0096-1. Epub 2015 May 19.
Daien CI, Pinget GV, Tan JK, Macia L Detrimental Impact of Microbiota-Accessible Carbohydrate-Deprived Diet on Gut and Immune Homeostasis: An Overview. Front Immunol. 2017 May 12;8:548. doi: 10.3389/fimmu.2017.00548. eCollection 2017.
Di Rosa C, Lattanzi G, Taylor SF, Manfrini S, Khazrai YM Very low calorie ketogenic diets in overweight and obesity treatment: Effects on anthropometric parameters, body composition, satiety, lipid profile and microbiota. Obes Res Clin Pract. 2020 Nov-Dec;14(6):491-503. doi: 10.1016/j.orcp.2020.08.009. Epub 2020 Sep 9.
Gregg EW, Shaw JE Global Health Effects of Overweight and Obesity. N Engl J Med. 2017 Jul 6;377(1):80-81. doi: 10.1056/NEJMe1706095. Epub 2017 Jun 12. No abstract available.
Gu Y, Yu H, Li Y, Ma X, Lu J, Yu W, Xiao Y, Bao Y, Jia W Beneficial effects of an 8-week, very low carbohydrate diet intervention on obese subjects. Evid Based Complement Alternat Med. 2013;2013:760804. doi: 10.1155/2013/760804. Epub 2013 Mar 14.
Lee MJ, Pickering RT, Puri V Prolonged efficiency of siRNA-mediated gene silencing in primary cultures of human preadipocytes and adipocytes. Obesity (Silver Spring). 2014 Apr;22(4):1064-9. doi: 10.1002/oby.20641. Epub 2013 Dec 5.
Li Y, Luo W, Deng Z, Lei G Diet-Intestinal Microbiota Axis in Osteoarthritis: A Possible Role. Mediators Inflamm. 2016;2016:3495173. doi: 10.1155/2016/3495173. Epub 2016 Aug 17.
Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9.
Meidenbauer JJ, Mukherjee P, Seyfried TN The glucose ketone index calculator: a simple tool to monitor therapeutic efficacy for metabolic management of brain cancer. Nutr Metab (Lond). 2015 Mar 11;12:12. doi: 10.1186/s12986-015-0009-2. eCollection 2015.
Moriconi E, Camajani E, Fabbri A, Lenzi A, Caprio M Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes. Nutrients. 2021 Feb 26;13(3):758. doi: 10.3390/nu13030758.
Paoli A, Bosco G, Camporesi EM, Mangar D Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015.
Peisl BYL, Schymanski EL, Wilmes P Dark matter in host-microbiome metabolomics: Tackling the unknowns-A review. Anal Chim Acta. 2018 Dec 11;1037:13-27. doi: 10.1016/j.aca.2017.12.034. Epub 2017 Dec 30.
Piaggi P, Vinales KL, Basolo A, Santini F, Krakoff J Energy expenditure in the etiology of human obesity: spendthrift and thrifty metabolic phenotypes and energy-sensing mechanisms. J Endocrinol Invest. 2018 Jan;41(1):83-89. doi: 10.1007/s40618-017-0732-9. Epub 2017 Jul 24.
Podsiadlo D, Richardson S The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Rondanelli M, Gasparri C, Peroni G, Faliva MA, Naso M, Perna S, Bazire P, Sajuox I, Maugeri R, Rigon C The Potential Roles of Very Low Calorie, Very Low Calorie Ketogenic Diets and Very Low Carbohydrate Diets on the Gut Microbiota Composition. Front Endocrinol (Lausanne). 2021 May 14;12:662591. doi: 10.3389/fendo.2021.662591. eCollection 2021. Erratum In: Front Endocrinol (Lausanne). 2021 Dec 22;12:825790.
Rothberg AE, McEwen LN, Kraftson AT, Fowler CE, Herman WH Very-low-energy diet for type 2 diabetes: an underutilized therapy? J Diabetes Complications. 2014 Jul-Aug;28(4):506-10. doi: 10.1016/j.jdiacomp.2014.03.014. Epub 2014 Mar 29.
Steven S, Hollingsworth KG, Al-Mrabeh A, Avery L, Aribisala B, Caslake M, Taylor R Very Low-Calorie Diet and 6 Months of Weight Stability in Type 2 Diabetes: Pathophysiological Changes in Responders and Nonresponders. Diabetes Care. 2016 May;39(5):808-15. doi: 10.2337/dc15-1942. Epub 2016 Mar 21. Erratum In: Diabetes Care. 2018 Apr 24;:
Very low-calorie diets National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. JAMA. 1993 Aug 25;270(8):967-74.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.