Implementing a low-carbohydrate diet in adults to manage type 1 diabetes mellitus: a standard of care protocol
Background: Type 1 diabetes mellitus is an autoimmune disease characterized by the destruction of pancreatic beta cells and absolute insulin deficiency. After the discovery of insulin, guidelines recommended 50% to 60% of carbohydrate consumption in individuals with diabetes. However, this recommendation is ineffective, since carbohydrate is the macronutrient that causes the greatest increase in blood glucose. The aim of this research is to evaluate the efficacy of a low-carbohydrate diet in adults with type 1 diabetes mellitus.
Methods: The study is a 26 weeks clinical trial. During the first 15 days, participants will receive approximately 130 g of daily carbohydrates, followed by a phase of 7 days, with the consumption of 90 g of daily carbohydrates, and finally, the consumption of 50 g of carbohydrates. The target audience is 20 participants diagnosed with type 1 diabetes mellitus, glycated hemoglobin (HbA1c) >7.0% and aged between 21 and 50 years, in addition to the parameters defined in the established inclusion and exclusion criteria. The primary outcome is HbA1c. Glycemic variability, frequency of hypoglycemia, total daily insulin and improvement in quality of life will also be evaluated.
Conclusions: Despite the evidence that low carbohydrate is effective for treating type 2 diabetes, there is low evidence for the recommendation in people with type 1 diabetes. In order to improve quality of life of this group and guidelines of clinical practice, and to promote development of health care professionals, further well-designed trials are needed.
Trial registration: The trial was registered at https://ensaiosclinicos.gov.br/rg/RBR-107jk4tn.
ADA. American Diabetes Association. Diagnostics and classification of diabetes Mellitus. Diabetes Care. 2014;37:81-90.
Cobo-Vuilleumier N, Gauthier BR. Time for a paradigm shift in treating type 1 diabetes Mellitus: coupling inflammation to islet regeneration. Metabolism Clinical and Experimental. 2020;104(154137).
DiMeglio L, Evans-Molina C, Oram RA. Type 1 diabetes. Lancet. 2018;391(10138):2449-62.
International Diabetes Federation. Atlas de Diabetes da IDF, 9º edição, 2019. Available at: https://www.diabetesatlas.org/en/. Accessed on 25 August 2021.
World Health Organization. Diabetes. 2020. Available at: https://www.who.int/news-room/fact sheets/detail/diabetes#:~:text=Diabetes%20is%20a%20major%20causehigh%20blood%20glucose%20in%202012. Accessed on 14 September 2021.
Brazilian diabetes society. Brazilian Society of Diabetes Guidelines 2019-2020, 2019.
ADA. American Diabetes Association. Statistics about Diabetes. 2018. Available at: https://www.diabetes.org/resources/statistics/statistics-about-diabetes. Accessed on 20 May 2020.
Kahanovitz I, Sluss PM, Russell SJ. Type 1 diabetes – A clinical perspective. Point Care. 2018;16(1):37-40.
Casqueiro J, Casqueiro J, Alves C. Infections in patients with diabetes Mellitus: A review of pathogenesis. Indian J Endocrinol Metab. 2012;16(1):27-36.
Atkilt HS, Turago MG, Tegegne BS. Clinical Characteristics of Diabetic Ketoacidosis in Children with Newly Diagnosed Type 1 Diabetes in Addis Ababa, Ethiopia: A Cross-Sectional Study. PLoS One. 2017;12(1):e0169666.
Benoit SR; Zhang Y, Geiss LS, Gregg EW, Albright A. Trends in Diabetic Ketoacidosis Hospitalizations and In-Hospital Mortality - United States, 2000-2014. Centers for Disease Control and Prevention. 2018;67(12):362-5.
Duca LM, Wang B, Rewers M, Rewers A. Diabetic Ketoacidosis at Diagnosis of Type 1 Diabetes Predicts Poor Long-term Glycemic Control. Diabetes Care. 2017;40(9):1249-55.
Dabelea D, Rewers A, Stafford JM, Standford DA, Lawrence JM, Saydah S, Imperatore G, Mayer-Davis E J, Pihoker C. Trends in the prevalence of ketoacidosis at diabetes diagnosis: the SEARCH for diabetes in youth study. Pediatrics. 2014;130(4):938-45.
Turton JL, Raab R, Rooney KB. Low-carbohydrate diets for type 1 diabetes Mellitus: A systematic review. Plos One. 2018;13(3):e0194987.
Feinman RD, Pogozelski WK, Astrup A, Bernstein RK, Fine EJ, Westman E, et al. Dietary carbohydrate restriction as the first approach in diabetes management: Critical review and evidence base. Nutrition. 2015;31(1):1-13.
Moreira ED, Neves RCS, Nunes ZO, Almeida MCCA, Mendes ABV, Fittipaldi JASF, Ablan F. Glycemic control and its correlates in patients with diabetes in Venezuela: Results from a nationwide survey. Diabetes Research and Clinical Practice. 2010;87(3):407-14.
Sastre J, Pinés P J, Moreno J, Aguirre M, Blanco B, Calderón D, Herranz S, Roa C, Lopez J. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the Diabetes type 1 in Castilla La Mancha study. Endocrinología y Nutrición. 2012;59(9):539-46.
De Souza ACCB, Felício JS, Koury CC, Neto JFAN, Miléo KB, Santos FM, et al. Health-related quality of life in people with type 1 Diabetes Mellitus: data from the Brazilian Type 1 Diabetes Study Group. Health and Quality of Life Outcomes. 2015;13(1):204.
Craig M, Twigg S, Donaghue K. National evidence-based clinical care guidelines for type 1 diabetes in children, adolescents and adults. 2011. Available at: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi27aWf5rj1AhUGzjgGHWQBD-4QFnoECAgQAQ&url=https%3A%2F%2Fdiabetessociety.com.au%2Fdocuments%2FType1guidelines14Nov2011.pdf&usg=AOvVaw1Bc6Vk43pzDAdn9jhJjEPw. Accessed on 20 May 2020.
McKnight JA, Wild SH, Lamb MJ. Glycaemic control of Type 1 diabetes in clinical practice early in the 21st century: an international comparison. Diabetic Med J Bri Diabetic Assoc. 2015;32:1036-50.
Juutilainen A, Lehto S, Rõnnemaa T, Pyorala K, Laakso M. Similarity of the impact of type 1 and type 2 diabetes on cardiovascular mortality in middle-aged subjects. Diabetes Care. 2008;31(4):714-9.
Kelly CT, Mansoor J, Dohm GL. Hyperinsulinemic syndrome: the metabolic syndrome is broader than you think. Surgery. 2014;156:405-11.
Wang MY, Yu X, Lee Y. Latrogenic hyperinsulinemia in type 1 diabetes: its effect on atherogenic risk markers. Journal diabetes its complications. J Diabetes Complications. 2013;27:70-4.
Kolic J, Johson JD. Promises and pitfalls of beta cell–replacement therapies. Nature Metabolism. 2021;3:1036-7.
Wang MY, Yu X, Lee Y, McCorkle K, Clark GO, Strowig S, Unger RH, Raskin P. Iatrogenic hiperinsulinemia in type 1 diabetes: Its effect on atherogenic risk markers. J Diabetes Complic. 2013;27(1):70-4.
Bahia L, Kupfer R, Momesso D, Cabral DAP, Tschiedel B, Puñales M, et al. Health-related quality of life and utility values associated to hypoglycemia in patients with type 1 diabetes Mellitus treated in the Brazilian Public Health System: a multicenter study. Diabetology & Metabolic Syndrome. 2017;9:9.
Orozco-Beltrán D, Artola S, Jansá M, Torre-Casares ML, Fuster E. Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes Mellitus patients: development and validation of a specific QoLHYPO© questionnaire. Health and Quality of Life Outcomes. 2018;16(52).
Bassuk S S, Manson J E. Epidemiological evidence for the role of physical activity in reducing risk of type 2 diabetes and cardiovascular disease. J Appl Physiol. 2005;99(3):1193-204.
Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes Mellitus: A Review. Int J Health Sci (Qassim). 2017;11(2):65-71.
Sainsbury E, Kizirian NV, Partridge SR. Effect of dietary carbohydrate restriction on glycemic control in adults with diabetes: A systematic review and meta-analysis. Diabetes Rese Clin Practice. 2018;139:239-52.
Patton SR. Adherence to Diet in Youth with Type 1 Diabetes. J Am Diet Assoc. 2011;111(4):550-5.
Oosterveer P. Globalization and sustainable consumption of shrimp: Consumers and governance in the global space of flows. Int J Consumer Stud. 2006;30(5):465-76.
Rahati S, Shahraki M, Arjomand G, Shahraki T. Food Pattern, Lifestyle and Diabetes Mellitus. International Journal of High Risk Behaviors and Addiction. 2014;3(1):e8725.
Wylie-Rosett J, Aebersold K, Conlon B, Isasi CR, Ostrovsky NW. Health effects of low-carbohydrate diets: Where should new research go? Current Diabetes Reports. 2013;13(2):271-8.
Ludwig DS, Ebbeling CB. The carbohydrate-insulin model of obesity. JAMA Internal Medicine. 2018;178(8):1098.
Wolpert HA, Atakov-Castillo A, Smith SA, Steil GM. Dietary fat acutely increases glucose concentrations and insulin requirements in patients with type 1 diabetes: implications for carbohydrate-based bolus dose calculation and intensive diabetes management. Diabetes Care. 2013;36:810-6.
Osler W, McCrae T. The principles and practice of medicine: New York, London, D. Appleton and company. 1920;1201.
Nielsen JV, Gando C, Paulsson JC. Low carbohydrate diet in type 1 diabetes long-term improvement and adherence: A clinical audit. Diabetology & Metabolic Syndrome. 2012;4(1):23.
Krebs JD, Strong AP, Cresswell P, Reynolds AN, Hanna A, Haeusler S. A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account. Asia Pacific Journal of Clinical Nutrition. 2016;25(1):78-84.
Buyken A E, Toeller M, Heitkamp G. Carbohydrate sources and glycaemic control in Type 1 diabetes Mellitus. EURODIAB IDDM Complications Study Group. Diabetic medicine J Bri Diabetic Association. 2000;17:351-9.