The Adaptation of the Carbohydrate Counting Method Affects HbA1c and Improves Anthropometric Indicators in Patients With Diabetes Mellitus 2

Abstract

The worldwide growth of diabetes mellitus (DM) has, in recent years, generated an exponential increase in associated comorbidities such as high blood pressure, cholesterol, and cardiovascular risk (CVR), with an increase in mortality in the population (1). At the same time, the global DM pandemic increased by 75% in recent decades, with a large proportion of affected individuals spanning all age groups from 1988 to 2010 (2). In the Americas, its prevalence has increased from 5 to 8.3% in recent years, particularly in Honduras, where 6% of individuals over 20 years of age have DM (3). As such, DM increases health care costs in low- and middle-income nations (4). Diagnosing diabetes mellitus type 2 (DM2) has changed since the inclusion of glycosylated hemoglobin (HbA1-c), as it is ≥6.5% in DM2. The criterion for fasting glucose is ≥126 mg/dL, whereas glucose at 2 h is ≥200 mg/dL (5). A hyperglycemic state can lead to an underlying prothrombotic environment, an overactivation of the coagulation cascade, fatal thromboembolic complications, and, eventually, increased mortality in DM patients (6). Medical treatment focuses on three pillars: drugs, nutrition, and education (7). The use of metformin acts as a standard pharmacological insulin used by patients to avoid weight gain (8). Nutritional medical therapy (NMT) prioritizes glycemic control and reduces comorbidities (7, 9). The diet promotion program is based on dietary guidelines, with group physical activity proving effective for predicting DM2 sowing but ineffective for long term benefits due to the lack of adherence (10). To this effect, the American Diabetes Association emphasized the need for individualized medical nutritional therapy (IMNT) (11). Carbohydrate counting (CCHO) has been shown to be effective for glycemic control in diabetes mellitus type 1 patients when being intensively treated with insulin (12, 13). Carbohydrate counting considers the actual content of food consumed based on the individual's usual intake and coordinates insulin-glucose utilization so that both curves act as a single exponentially flattened growth curve (14). The resulting weight gain is a consequence of decreased urine sugar loss (15). Few studies have used carbohydrate counting in DM2 in the primary care setting, and although it showed improvements in HbA1c, compression of carbohydrate counting was considered difficult for participants (16). Given the paucity of evidence from randomized controlled clinical trials in Latin American for carbohydrate counting DM2 patients, this work aimed to evaluate the effectiveness of this medical nutritional treatment, which minimizes the risk of developing comorbidities and public spending on health care. The present work was a double-blind randomized controlled clinical trial. The allocation of the University School Hospital of Honduras was random. The study design was submitted and approved by the Biomedical Research Ethics Committee (IRB N°419-CGPGFCM/UNAH/2017) of the National Autonomous University of Honduras, on June 9, 2017. The doctors and nutritionists assigned to this study took an online ethics course titled “Human Subjects Research, IRB, Behavioral and Educational Focus” via the Collaborative Institutional Training program. As such, they were in compliance with the CONSORT checklist (17), which states the information to be included when reporting a randomized clinical trial. The study was carried out at the National Autonomous University of Honduras. The University School Hospital of Honduras has a specialized unit for the comprehensive care of DM patients and has recently created facilities conducive to the interdisciplinary medical-nutritional approach named “Model Center for Training and Comprehensive Care in Diabetes.” It has become the most prominent medical center in Honduras. The working group was made up of the clinical epidemiology unit and the endocrinology unit belonging to the University School Hospital of Honduras. The director of the Model Center for Training and Comprehensive Care in Diabetes selected two doctors to adjust drug treatments and two nutritionists to apply and follow up with the carbohydrate (CCHO) count and current dietary recommendations (RDC). The working groups were trained separately for the application of nutritional medical therapies. The randomization of the participants was carried out by the head of the clinical epidemiology service. using the “random” function in Microsoft Excel. Participants with a DM2 diagnosis were selected based on clinical records, glycosylated hemoglobin ≥7% (not older than 6 months), aged between 18 and 65 years, insulin use between 1 and 10 years, no use of sulfonylureas, body mass index (BMI) <35 kg/m2, and waist–hip ratio ≥0.90 in men and ≥0.85 in women. Patients excluded were those who had been clinically diagnosed as having cancer, chronic respiratory disease, pregnancy, cognitive impairment (e.g., dementia, amnesia, delirium), macroangiopathy (e.g., ischemic heart disease, stroke, peripheral vascular disease), microangiopathy (e.g., proliferative retinopathy or maculopathy, kidney failure grade IIb, III, or IV), amputations, temporary staff of the institution, and those with insulin use over 10 years. In 2016, the diabetic population of the University School Hospital of Honduras was 4,247 patients. In this study, 400 eligible patients in the endocrinology unit were selected. A mean value of 8.33% glycosylated hemoglobin was considered a regular value (11). For the sample size, we assumed risks foreseen in the current dietary recommendations of the control group (10%). The risk value of making an error was the conventional alpha of 5% (bilateral hypothesis) and beta of 20%. Participants (n = 62), per medical nutritional treatment, were adjusted for 15% loss and resulted in 71 participants per carbohydrate counting group for the current dietary recommendations. Figure 1...