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Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial.
Perichart-Perera, O, Mier-Cabrera, J, Flores-Robles, CM, Martínez-Cruz, N, Arce-Sánchez, L, Alvarado-Maldonado, IN, Montoya-Estrada, A, Romo-Yañez, J, Rodríguez-Cano, AM, Estrada-Gutierrez, G, et al
Nutrients. 2021;(1)
Abstract
The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m2, insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 (n = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 (n = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was n = 11 (24.4%) in the MNT plus metformin group versus n = 7 (15.5%) in the MNT without metformin group: p = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: NCT01675310.
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Improving growth of infants with congenital heart disease using a consensus-based nutritional pathway.
Marino, LV, Johnson, MJ, Davies, NJ, Kidd, CS, Fienberg, J, Richens, T, Bharucha, T, Beattie, RM, Darlington, AE
Clinical nutrition (Edinburgh, Scotland). 2020;(8):2455-2462
Abstract
OBJECTIVE Infants with congenital heart disease (CHD) often experience growth failure prior to surgery, which is associated with increased paediatric-intensive-care unit length of stay (PICU-LOS) and post-operative complications. This study assessed the impact of a pre-operative, consensus-based nutritional pathway (including support from a multi-disciplinary team) on growth and clinical outcome. DESIGN Single-centre prospective pilot study. SETTING Tertiary paediatric cardiology surgical centre. PATIENTS Infants with CHD. INTERVENTION Infants with CHD were followed for up to 4-months-of-age before cardiac surgery and then to 12-months-of-age following the implementation of the consensus-based nutritional-pathway (Intervention group: November 2017-August 2018), with outcomes compared to a historic control group. The nutrition pathway involved a dietitian contacting parents of infants with the highest risk of growth failure weekly; reviewing weight gain and providing feeding support. MAIN OUTCOME MEASURE Growth (weight-for-age, WAZ, and height-for-age-z-score, HAZ) at 4 and 12 months-of-age. RESULTS 44 infants in the intervention group were compared to 38 in the control group. Median (inter quartile range) change in WAZ from birth to 4 months-of-age (-0.9 (-1.5, 0.7)) and from birth to 12 months-of-age (-0.09 (-1.3, 1.1)) in the intervention group compared to the control group (-1.5 (-2.0, -0.4) (p = 0.04)) at 4 months-of age and at 12 months-of-age (-0.4 (1.9, 0.2) (p = 0.03)). HAZ at 4 months-of-age was -0.7 (-1.4, -0.1) vs. -1.0 (-1.9, -0.3) (p = 0.6) in the intervention and control groups respectively, and at 12 months-of-age HAZ was -0.7 (-1.9, -0.07) in the intervention group vs.-1.6 (-2.6, -0.4) in the control group (p = 0.04). Duration of PICU-LOS was 8.2 ± 11.6 days intervention vs. 18.3 ± 24.0 days control (p = 0.006). CONCLUSION Overall weight was well maintained and growth improved in infants who followed the pre-operative nutritional-pathway. The duration of PICU-LOS was significantly lower in the intervention group, which may be due to improved nutritional status, although this requires further investigation.
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Plasma proteomics reveals markers of metabolic stress in HIV infected children with severe acute malnutrition.
Gonzales, GB, Njunge, JM, Gichuki, BM, Wen, B, Potani, I, Voskuijl, W, Bandsma, RHJ, Berkley, JA
Scientific reports. 2020;(1):11235
Abstract
HIV infection affects up to 30% of children presenting with severe acute malnutrition (SAM) in Africa and is associated with increased mortality. Children with SAM are treated similarly regardless of HIV status, although mechanisms of nutritional recovery in HIV and/or SAM are not well understood. We performed a secondary analysis of a clinical trial and plasma proteomics data among children with complicated SAM in Kenya and Malawi. Compared to children with SAM without HIV (n = 113), HIV-infected children (n = 54) had evidence (false discovery rate (FDR) corrected p < 0.05) of metabolic stress, including enriched pathways related to inflammation and lipid metabolism. Moreover, we observed reduced plasma levels of zinc-α-2-glycoprotein, butyrylcholinesterase, and increased levels of complement C2 resembling findings in metabolic syndrome, diabetes and other non-communicable diseases. HIV was also associated (FDR corrected p < 0.05) with higher plasma levels of inflammatory chemokines. Considering evidence of biomarkers of metabolic stress, it is of potential concern that our current treatment strategy for SAM regardless of HIV status involves a high-fat therapeutic diet. The results of this study suggest a need for clinical trials of therapeutic foods that meet the specific metabolic needs of children with HIV and SAM.
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An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO.
Märten, A, Wente, MN, Ose, J, Büchler, MW, Rötzer, I, Decker-Baumann, C, Karapanagiotou-Schenkel, I, Harig, S, Schmidt, J, Jäger, D
BMC cancer. 2009;:412
Abstract
BACKGROUND Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival. Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for. METHODS/DESIGN PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first). DISCUSSION The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma. TRIAL REGISTRATION Current Controlled Trials ISRCTN60516908.
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Effect of nutritional counselling on hepatic, muscle and adipose tissue fat content and distribution in non-alcoholic fatty liver disease.
Thomas, EL, Brynes, AE, Hamilton, G, Patel, N, Spong, A, Goldin, RD, Frost, G, Bell, JD, Taylor-Robinson, SD
World journal of gastroenterology. 2006;(36):5813-9
Abstract
AIM: To assess the effectiveness of the current UK clinical practice in reducing hepatic fat (IHCL). METHODS Whole body MRI and (1)H MRS were obtained, before and after 6 mo nutritional counselling, from liver, soleus and tibialis muscles in 10 subjects with non-alcoholic fatty liver disease (NAFLD). RESULTS A 500 Kcal-restricted diet resulted in an average weight loss of 4% (-3.4 kg,) accompanied by significant reductions in most adipose tissue (AT) depots, including subcutaneous (-9.9%), abdominal subcutaneous (-10.2%) and intra-abdominal-AT (-11.4%). Intramyocellular lipids (IMCL) were significantly reduced in the tibialis muscle (-28.2%). Decreases in both IHCL (-39.9%) and soleus IMCL (-12.2%) content were also observed, although these were not significant. Several individuals showed dramatic decreases in IHCL, while others paradoxically showed increases in IHCL content. Changes in body composition were accompanied by improvements in certain liver function tests: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Significant correlations were found between decreases in IHCL and reductions in both intra-abdominal and abdominal subcutaneous AT. Improvements in liver function tests were associated with reductions in intra-abdominal AT, but not with changes in IHCL. CONCLUSION This study shows that even a very modest reduction in body weight achieved through lifestyle modification can result in changes in body fat depots and improvements in LFTs.