Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum.

Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-classes. This summary by the Liver Forum's Standard of Care Working Group reviews currently available clinical data, identifies the barriers and challenges associated with the standard of care in NAFLD/NASH clinical trials, defines available assessments of lifestyle changes, and proposes approaches to better understand and define the influence of diet and exercise on NASH treatment in the context of different pharmacologic interventions. The ultimate objective is to propose tangible solutions which enable investigators, sponsors, and regulatory authorities to meaningfully interpret clinical trial outcomes and the impact of lifestyle modification on such outcomes as they pertain to phase I-IV clinical trials.

A phase 2, adaptive randomized, double-blind, placebo-controlled, multicenter, 52-week study of HM15211 in patients with biopsy-confirmed non-alcoholic steatohepatitis - Study design and rationale of HM-TRIA-201 study.

Non-alcoholic steatohepatitis (NASH) is a multifactorial disease with an increasing prevalence worldwide due to the obesity pandemic. HM15211 (efocipegtrutide), a novel, long-acting glucagon-like peptide-1/glucagon/glucose-dependent insulinotropic polypeptide triple incretin agonist has shown promising efficacy in in vitro, preclinical rodent models of NASH and phase 1 studies with manageable toxicity. Though liver biopsy is recommended for grading and staging of NASH, its invasive nature necessitates innovative approaches in clinical trials that decrease the burden of patients otherwise subjected to this invasive procedure. We report an innovative study design of phase 2 study of HM15211. METHODS: HM-TRIA-201 is a multicenter, randomized, double-blind, 52-week, placebo-controlled, parallel-group adaptive design study of 217 patients with biopsy-proven NASH. The primary endpoint is the proportion of patients with complete resolution of steatohepatitis (defined as Non-alcoholic fatty liver disease Activity Score of 0-1 for inflammation, 0 for ballooning, and any other value for steatosis) on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network fibrosis score. An interim analysis is planned after 15 patients/group complete 26 weeks of treatment, after which one HM15211 dose group will be discontinued based on safety and efficacy risk-to-benefit analysis; patients of the dropped dosing arm will be re-randomized into 2 remaining HM15211 groups. CONCLUSION: The adaptive design study of HM15211 minimizes the number of patients to be exposed to a liver biopsy while optimizing the sample size of patients exposed to safe and effective doses of HM15211 to inform ideal dose for further clinical development in NASH.

Differential Associations of Circulating MicroRNAs With Pathogenic Factors in NAFLD.

Nonalcoholic fatty liver disease (NAFLD) is a heterogeneous disease driven by genetic and environmental factors. MicroRNAs (miRNAs) serve as pleiotropic post-transcriptional regulators of cellular pathways. Although several miRNAs have been associated with NAFLD and fibrosis, there are limited studies in humans examining their differential association with pathogenic factors or histological features of NAFLD. We examined the differential relationships of five of the best-described circulating microRNAs (miR-34a, miR-122, miR-191, miR-192, and miR-200a) with histological features and pathogenic factors of NAFLD. A cross-sectional study was conducted to examine the relationship between relative levels of circulating microRNAs standardized by z-scores and histological features of NAFLD, common NAFLD genetic polymorphisms, and insulin resistance measured by the enhanced lipoprotein insulin resistance index in 132 subjects with biopsy-proven NAFLD. We found that miR-34a, miR-122, miR-192, miR-200a, but not miR-191, strongly correlate with fibrosis in NAFLD by increases of 0.20 to 0.40 SD (P < 0.005) with each stage of fibrosis. In multivariate analysis, miR-34a, miR-122, and miR-192 levels are independently associated with hepatic steatosis and fibrosis, but not lobular inflammation or ballooning degeneration, whereas miR-200a is only associated with fibrosis. Among the four miRNAs, miR-34a, miR-122, and miR-192 are associated with pathogenic factors of NAFLD, including insulin resistance measured by eLP-IR, patatin-like phospholipase domain containing 3 I148M, and transmembrane 6 superfamily 2 (TM6SF2) E167K polymorphisms. In contrast, miR-200a is only associated with the TM6SF2 E167K variant. Finally, miR-34a has the strongest predictive value for various stages of fibrosis, with C-statistic approximates-combined predictive score for miRNAs. Conclusion: miR-34a, miR-122, miR-192, and miR-200a demonstrate strong associations with NAFLD severity by histology, but differential associations with pathogenic factors.

[Cardiovascular risk profile of uncontrolled hypertensive patients. The Control-Project study]. / Perfil de riesgo cardiovascular de los pacientes con hipertensión arterial no controlada. Estudio Control-Project.

BACKGROUND AND OBJECTIVE: To assess absolute cardiovascular risk and co-morbidities in uncontrolled hypertensive patients (blood pressure [BP]>or=140/90 mmHg or>or=130/80 mmHg in diabetics) attending Primary Care Physicians in Spain, and to determine the attitudes of these physicians towards this problem. PATIENTS AND METHOD: Cross-sectional, multicenter study involving 356 general practitioners around Spain. Absolute cardiovascular risk was assessed according to ESH-ESC 2003 Guidelines in a sample of 1,710 patients. RESULTS: Two hundred ninety seven patients were excluded by several reasons and a total of 1,413 hypertensive patients were valuable (mean age: 65.3+/-11.4 years; 56.7% women). Normal BP values (<140/90 mmHg) were exhibited by 0.2%, high-normal BP (120-139/80-89 mmHg) were exhibited by 2.8%, grade 1 hypertension (140-159/90-99 mmHg) by 49.9%, grade 2 hypertension (160-179/100-109 mmHg) by 39.3%, and grade 3 hypertension (>or=180/110 mmHg) by 7.9%. Associated cardiovascular risk factors were observed in 96.0% of patients (95% CI=94.7-97.2%), target organ damage in 34.5% (95% CI=31.6-36.5%), and cardiovascular clinical disease in 36.0% (95% CI=33.5-38.5%). According to ESH-ESC 2003 Guidelines 34.0% (CI=31.5-38.2%) were at very-high risk; 29.4% (95% CI=26.4-32.8%) at high risk; 30.4% (95% CI=27.2-33.7%) at moderate risk and 5.4% (95% CI=3.9-7.2%) at low risk of cardiovascular disease. Despite the high absolute risk, physicians did not do any therapeutic change in 30.4% (95% CI=28.2-33.5%) of uncontrolled hypertensive patients. Most of them (64.26%) considered that bad compliance to life style changes was the reason for inadequate BP control. The most frequent measure introduced was the association of additional drugs. CONCLUSIONS: Absolute cardiovascular risk in uncontrolled hypertensive patients attending Primary Care Physicians in Spain is very relevant. Sixty-five percent of these patients are at high or very high risk with a high prevalence of target organ damage or associated cardiovascular clinical disease. Therapeutic attitudes towards these patients are still very conservative although they are improving compared with previous studies.

Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic.

Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic strategies for patients with this disease. Unfortunately, its long and asymptomatic natural history, the uncertainties about disease progression, the fact that most patients are undiagnosed, and the requirement for sequential liver biopsies create substantial challenges for clinical development. Adaptive design methods are increasingly used in clinical research as they provide the flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation and make prompt preplanned adaptations without undermining the validity or integrity of the trial. Given the high unmet medical need and the lack of validated surrogate endpoints in NASH, the use of adaptive design methods appears reasonable. Furthermore, due to the limited number of patients willing to have multiple liver biopsies and the need for long-term exposure to assess an impact in outcomes, a continuous seamless adaptive design may reduce the overall sample size while allowing patients to continue after each one of the phases. Here, we review strategic frameworks that include potential surrogate endpoints as well as statistical and logistical approaches that could be considered for applying adaptive designs to clinical trials in NASH with the goal of facilitating drug development for this growing medical need. (Hepatology Communications 2017;1:577-585).

[Management of type 2 diabetic patients in primary care in Spain]. / Tratamiento de los pacientes con diabetes mellitus tipo 2 en atención primaria en España.

BACKGROUND AND OBJECTIVE: We assess the metabolic control, complications, quality of life related to health (QLRH) and the type and amount of medical resource consumption (MRC) in type 2 diabetic patients (2DMp) followed by primary care physicians (PCP) in Spain. PATIENTS AND METHOD: We studied 628 2DMp divided in 4 cohorts: 1. Either newly diagnosed 2DMp who required pharmacological treatment or failed to non-pharmacological measures; 2. Patients pharmacologically treated for less than 1 year; 3. Patients with pharmacological treatment for more than 1 year; 4. Patients with impaired fasting glucose (control group). RESULTS: Eighty percent of the subjects were overweight. At baseline, 27.9, 23.5 and 36.9% of patients from cohorts 1, 2 and 3, respectively, had HbA1C < 8%. After 6 months of follow-up, 14.6, 21.3 and 22.8% of patients from cohorts 1, 2 and 3, respectively, still had "bad control". At baseline, 38.0%, 21.2% and 20.7% of patients from cohorts 1, 2, and 3, respectively, had "bad lipid profile". After 6 months, 57.4%, 54.2% and 45.3% of cohorts 1, 2 and 3, respectively, still had plasma cLDL levels > 130 mg/dl. Complications were more frequent in cohort 3. During the 6-month period, MRC was higher among 2DMp than controls (p < 0.05) and higher among patients from cohort 3 (p < 0.05) compared with all the other patients. More diabetic than control patients and more patients from cohort 3 than patients from cohort 1 and 2 reported that their expected quality of life would be better without diabetes. CONCLUSIONS: One out of four of diabetic patients studied had HbA1C and lipids higher than the limits suggested by guidelines. Type 2 diabetes is associated with higher MRC and worse QLRH. This situation is worse among long-term diabetic patients.

Non-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval Pathway.

The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is increasing world-wide in parallel to the increase of the obesity epidemic. Insulin resistance (IR) and the accumulation of triglyceride-derived toxic lipid metabolites play a key role in its pathogenesis. Multiple biomarkers are being evaluated for the non-invasive diagnosis of NASH. However, a percutaneous liver biopsy is still the gold standard method; the minimal diagnostic criteria include the presence of >5% macrovesicular steatosis, inflammation, and liver cell ballooning. Several pharmaceutical agents have been evaluated for the treatment of NASH; however, no single therapy has been approved so far. Due to the increasing prevalence and the health burden, there is a high need to develop therapeutic strategies for patients with NASH targeting both those with early-stage disease as well as those with advanced liver fibrosis. There are unique challenges in the design of studies for these target populations. Collaborative efforts of health authorities, medical disease experts, and the pharmaceutical industry are ongoing to align options for a registrational pathway. Several companies pursuing different mechanisms of action are nearing the end of phase II with their candidates. This manuscript reviews those compounds with a variety of mode of actions that have been evaluated and/or are currently being tested with the goal of achieving a NAFLD/NASH indication.

Effect of vildagliptin as add-on therapy to a low-dose metformin.

AIM: To evaluate the efficacy and safety of the addition of vildagliptin to low-dose metformin and compare it to an uptitration of metformin in type 2 diabetes mellitus (T2DM) patients who have inadequate control with metformin monotherapy. METHODS: Eligible patients were randomized to receive vildagliptin 100 mg qd or metformin (500 mg qd for 2 wk and then 500 mg bid) added to open label metformin 500 mg bid for the 24 wk. The primary endpoint was baseline to endpoint hemoglobin A(1c) (HbA(1c)) change. RESULTS: The adjusted mean change from baseline in HbA(1c) at the 24th wk was -0.51% in the vildagliptin/metformin group (mean baseline HbA(1c): 7.4%) and -0.37% in the metformin monotherapy group (mean baseline HbA(1c): 7.3%). The mean difference was -0.14% with 95% Confidence Interval (-0.24%, -0.05%). As non-inferiority (margin of 0.4%) was achieved, a test for superiority was performed. This test showed statistically significant superiority of the combination over monotherapy group (P = 0.002). Gastrointestinal (GI) adverse events were significantly more frequent in the metformin group than the combination group (21.0% vs 15.4%, P = 0.032). CONCLUSION: In patients with T2DM inadequately controlled with metformin up to 1000 mg daily, the addition of vildagliptin 100 mg daily achieved larger HbA(1c) reduction with fewer GI events than with increasing the metformin dose.

Efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with diabetes.

AIM: To assess the efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with type 2 diabetes mellitus (T2DM). METHODS: This was a post hoc analysis in Korean patients, from a 24-wk, randomized, active-controlled, double-blind, parallel-group, multicenter study. Eligible patients were aged between 18 and 80 years, drug naive, and had been diagnosed with T2DM [hemoglobin A(1c) (HbA(1c)): 7.5%-11.0% and fasting plasma glucose (FPG): < 270 mg/dL (< 15 mmol/L)]. Patients were randomized (1:1:1:1) to receive the vildagliptin/pioglitazone combination at 100/30 mg q.d. (high-dose) or 50/15 mg q.d. (low-dose), vildagliptin 100 mg q.d., or pioglitazone 30 mg q.d. monotherapies. The primary outcome measure was change in HbA(1c) from baseline to endpoint. RESULTS: The distribution of baseline demographic and clinical parameters was well balanced between treatment groups. The overall mean age, body mass index, HbA(1c), FPG, and duration of disease were 50.8 years, 24.6 kg/m(2), 8.6%, 10.1 mmol/L, and 2.2 years, respectively. Adjusted mean changes (± standard error) in HbA(1c) from baseline (~8.7%) to week 24 endpoint were -2.03% ± 0.16% (high-dose, N = 34), -1.88% ± 0.15% (low-dose, N = 34), -1.31% ± 0.21% (vildagliptin, N = 36), and -1.52% ± 0.16% (pioglitazone, N = 36). The high-dose combination therapy demonstrated greater efficacy than monotherapies [vildagliptin (P = 0.029) and pioglitazone (P = 0.027)]. Percentage of patients achieving HbA(1c) < 7% and ≤ 6.5% was the highest in the high-dose group (76% and 68%) followed by low-dose (58% and 47%), vildagliptin (59% and 37%), and pioglitazone (53% and 28%) groups. The overall incidence of adverse events was comparable. CONCLUSION: In Korean patients, first-line treatment with high-dose combination therapy improved glycemic control compared to pioglitazone and vildagliptin monotherapies, consistent with results published for the overall study population.

Relationship between plasma levels of soluble CD40L and insulin sensitivity and insulin secretion status in non-diabetic dyslipidemic patients.

OBJECTIVE: We have measured circulating plasma sCD40L as well as the platelet-surface of CD40L and its receptor in a sample of non-diabetic dyslipidemic patients and then evaluated its relationship with the insulin resistance (IR) and insulin secretion (IS) status. DESIGN AND METHODS: Anthropometric measurements, fasting glucose, insulin, lipids, and IR and IS [estimated by the homeostasis model assessment (HOMA)] were assessed in 86 dyslipidemic subjects. Circulating sCD40L were determined by ELISA. By flow cytometry, CD40L, CD40 and P-selectin were evaluated in the platelet-surface. RESULTS: Non-diabetic dyslipidemic IR patients (HOMA-IR>or=3.8) showed higher plasma sCD40L concentrations and a more unfavorable cardiovascular risk profile (higher BMI, waist, fasting insulin and mean triglyceride levels) than dyslipidemic patients with low IS (HOMA beta-cell<98). In a multivariable model, only measures of insulin sensitivity and higher waist remained significantly associated with increased plasma levels of sCD40L. Surface expression of CD40L on platelets decreased significantly and CD40 increased in IR patients, compared with patients with low IS. CONCLUSIONS: IR dyslipidemic patients show increased plasma sCD40L and decreased platelet-membrane CD40L expression compared to dyslipidemic patients with low IS.

Prevalence of abnormal urinary albumin excretion rate in hypertensive patients with impaired fasting glucose and its association with cardiovascular disease.

The prevalence and significance of microalbuminuria in hypertensive patients with impaired fasting glucose (IFG) has received very little attention. A total of 10,320 hypertensive patients who attended primary care centers were enrolled in this study, and the final analysis was done in 7625 patients: 1459 without IFG (plasma glucose <100 mg/dl), 3010 with IFG (plasma glucose > or =100 mg/dl and <126 mg/dl), and 3156 with type 2 diabetes (plasma glucose >126 mg/dl). Microalbuminuria was determined using the Micro Albustix reactive strip from Bayer (high urinary albumin excretion [UAE]: Albumin/creatinine ratio > or =3.4 mg/mmol). The proportion of patients with high UAE was 39.4, 48.3, and 65.6%, respectively, in the three groups (P < 0.01 for the trend). The differences in UAE between the group with IFG and the group with normal fasting glucose persisted after adjustment for age, gender, systolic BP, fasting plasma glucose, and cardiovascular comorbidity (odds ratio 1.74; 95% confidence interval 1.08 to 2.80). Hypertensive patients with IFG and high UAE showed a higher prevalence of ischemic heart disease, cardiac insufficiency, left ventricular hypertrophy, atrial fibrillation, and renal insufficiency than the group with normal UAE. Global prevalence of cardiovascular conditions was 30.4% in the group with high UAE compared with 21.4% in the group with normal UAE (odds ratio 1.60; 95% confidence interval 1.31 to 1.95). It is concluded that almost half of hypertensive patients with IFG have high UAE and a higher prevalence of associated cardiovascular involvement and renal insufficiency.

Prevalence of renal insufficiency in individuals with hypertension and obesity/overweight: the FATH study.

Overweight and obesity are associated with increased cardiovascular risk. Some studies have demonstrated that they also can result in renal damage. The aim of this study was to assess the prevalence of renal insufficiency (RI), defined as a GFR <60 ml/min per 1.73 m2, in a cohort of 4585 patients who attended primary care with essential hypertension and a body mass index > or =25 kg/m2. The patients were classified as overweight and obese according to body mass index (25 to 29.9 and > or =30 kg/m2, respectively). Abdominal obesity was defined as a waist circumference > or =88 and 102 cm in women and men, respectively. Both groups had a high prevalence of metabolic syndrome (Adult Treatment Panel III). The prevalence of RI was high in both the overweight group (22.7%; 95% confidence interval [CI] 20.6 to 24.9) and in the obese group (22.8%; 95% CI 21.0 to 24.7). The presence of diabetes increased the risk for RI (odds ratio 1.83; 95% CI 1.55 to 2.16). The prevalence of RI was greater in patients with abdominal obesity (23 versus 17%; P < 0.001). In the presence of abdominal obesity, cardiovascular risk factors and components of the metabolic syndrome also were more prevalent. The higher risk for RI with abdominal obesity persisted even after adjustment for dyslipidemia, elevated blood glucose levels, and other variables that are associated with RI (adjusted odds ratio 1.40; 95% CI 0.84 to 2.33). It was concluded that patients who have hypertension and visceral obesity and attend primary care present a higher prevalence of metabolic syndrome and RI.

Urinary albumin excretion and glomerular filtration rate across the spectrum of glucose abnormalities in essential hypertension.

The objective of this study was to assess the relationship between urinary albumin excretion (UAE) and GF across the spectrum of the glucose metabolism abnormalities in a large population of patients with hypertension. The Microaluminuria en Pacientes con Glucemia Basal Alterada (MAGAL) is a multicenter, cross-sectional study that was carried out by 1723 primary care physicians. A total of 6227 patients with essential hypertension (in three groups: [1] normal fasting glucose <100 mg/dl, [2] impaired fasting glucose > or =100 to 126 mg/dl, and [3] type 2 diabetes) were analyzed in this substudy. GFR was estimated by using the Modification of Diet in Renal Disease (MDRD) abbreviated equation. A single first-morning urine albumin/creatinine ratio was measured using Bayer reagent strip Microalbustix, a semiquantitative method. Abnormal UAE was defined as an albumin/creatinine ratio > or =3.4 mg/mmol (equivalent to > or =30 mg/g). The prevalence of abnormal UAE, > or =3.4 mg/mmol, increased across the spectrum of glucose abnormalities: 39.7, 46.2, 48.6, and 65.6% for normoglycemic, low-range, and high-range impaired fasting glucose and diabetes, respectively. UAE was positively related to SBP (P = 0.003) and inversely to GFR (P < 0.001). Renal insufficiency (GFR <60 ml/min per 1.73 m2) was present in 21.8% of the patients, more frequently older patients, women, and those with diabetes. The factors that were related to renal insufficiency were UAE > or =3.4 mg/mmol (odds ratio 1.86; 95% confidence interval 1.60 to 2.17) and diabetes (odds ratio 1.62; 95% confidence interval 1.29 to 2.04). There is a close relationship between abnormal UAE and renal insufficiency in essential hypertension. This is more marked in patients with diabetes and moderate in patients with high-range impaired fasting glucose.

Péptidos involucrados en la regulación del balance energético / Peptides involved in the regulation of the energy balance

El estudio de la regulación del balance enérgetico parte del conocimiento de los efectos de las lesiones en hipotálamo lateral y medial en animales. La interrupción del hipotálamo ventromedial origina obesidad hiperfágica, mientras que la lesión del hipotálamo lateral causa hipofagia y pérdida de peso, sugiriendo la existencia de un centro ventromedial de la "saciedad" y un centro lateral o "del hambre". La inyección de hormonas y neuropéptidos presentes en el hipotálamo ayudó a reconocer los efectos de la noradrenalina, la dopamina y la serotonina, así como de neuropéptido Y, factor liberador de corticotrofina y galanina. Más recientemente, el reconocimiento de la leptina-el producto del gen ob-marcó el comienzo de una etapa de primordial importancia para la comprensión de la regulación del balance energético. La combinación de aproximaciones genéticas y bioquímicas permitió el reconociminto de numerosos mediadores de la acción de la leptina, así como de otros péptidos relacionados con el hambre-saciedad. La complejidad de este sistema dificulta el uso potencial de dicha hormona en el tratamiento de la obesidad humana

Epidemiología de la obesidad en América Latina / Obesity epidemiology in Latin America

Latinoamérica presenta una alta prevalecencia de obesidad, incrementada en los últimos años, y provocando un mayor riesgo en enfermedades crónicas en sus habitantes. Esta revisión de diferentes estudios realizados sobre el tema en la región sintetiza datos de tendencia, datos en población infantil, y en grupos indígenas. También analiza la asociación entre obesidad y diferentes factores de riesgo

Medicion del gasto energetico en niños a partir de la frequencia cardiaca y actividad / Heart rate and physical activity to assess energy expenditure en children

El objetivo del presente trabajo fue validar la estimación de gasto energético en niños a partir de la medición de la frecuencia cardíaca (FC) y del nível de actividad física en un período controlado de tiempo, para hacerlo extensible posteriormente a condiciones de vida libre. El método usado como patrón fue la calorimetría indirecta. Estudiamos 25 niños (12 mujeres, 13 varones), 12.1 + 0.7 años de edad. Durante aproximadamente 60 minutos, se midió el consumo de oxigeno (VO(2)) y la producción de dióxido de carbono (VCO(2)) por calorimetria indirecta. Las mediciones se realizaron en distintas situaciones: reposo, sentados, parados y caminando a 4 velocidades diferentes. Simultáneamente, se valoró, minuto por minuto la frecuencia cardíaca y el nivel de movimiento. Cada minuto de frecuencia caríaca (FC) fue convertido a VO(2)) y gasto energético, usando 2 ecuaciones diferentes para situaciones activas e inactivas. Cuando las cuentas (movimentos) fueron 7 o superiores en el minuto estudiado y los 2 minutos precedentes, y el valor de FC superior a un valor umbral prefijado (intersección de las líneas definidas por las 2 funciones) se utilizó una ecuación lineal ("activa"): (VO(2) = K + b FC). Una función cúbica se usó en los minutos restantes; "no activos": (VO(2) = K + b FC(3)). La media del consumo de oxigeno estimado por ecuación para cada minuto no difirió de la medida del valor medido por calorimetria (ANOVA, p = 0.99). El VO(2) medido correlacionó significativamente con el VO(2) estimado por las ecuaciones (r = 0.99, p < 0.01). Se halló, además, alto grado de acuerdo. Conclusiones. La combinación de la frecuencia cardíaca y el nivel de actividad física estimó el gasto energético con una precisión similar al método de calorimetría indirecta.

Asociación entre medidas antropométricas y alteraciones lipoproteicas en mujeres / Relationship between anthropometric measurements and lipoprotein abnormalities in women

Es sabido que el exceso de grasa corporal, principalmente sudistribución abdominal, incrementa los riesgos de alteraciones lipoproteicas. Elobjetivo de este estudio fue investigar en un grupo de mujeres que demandaron tratamiento antiobesidad, la asociación entre un set de mediciones antropométricas (MA) y un set de parámetros lipoproteicos (PLP), el peso de cada una de estas variables en la asociación y su valor predictivo. Estudiamos 105 mujeres (edad 40.2ñ 12) que concurrieron a diversos consultorios en busca de tratamiento antiobesidad. Las MA evaluadas fueron: índice de masa corporal (IMC), porcentaje de grasa corporal por el método de bioimpedancia eléctrica (BIA), cintura, cintura/cadera (C/C), y cuello. Los PLP estudiados fueron: colesterol total (CT), LDL y HDLcolesterol y triglicéridos (trig.) Por el análisis de correlación simple hallamos asociación entre cada una de las MA y los niveles de trig. La asociación entre CT e IMC, BIA, cintura y C/C fue menor pero significativa. La correlación entreel set de MA y el de PLP fue estudiada por el modelo de correlación canónica, hallándose correlacilón global altamente significativa (r=0.612,p<0.00012). Los niveles de trig, colesterol y LDL se hallaron significativamente asociados con lasMA. Mediante el análisis de regresión lineal múltiple, hallamos asociación entrecintura y niveles de trig. Conclusiones: Se halló asociación entre el set de MA y el set de PLP. La distribución abdominal del exceso graso valorado por el perímetro de la cintura fue el mejor predictor de hipertrigliceridemia