A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial.

OBJECTIVE: Excessive weight gain is common after kidney transplantation and increases cardiovascular risk. The aim of this randomized controlled trial was to determine whether an intensive nutrition and exercise intervention delivered alongside routine post-transplant care would reduce post-transplant weight gain. DESIGN: Single-blind, randomized controlled trial. SUBJECTS AND SETTING: Adult kidney transplant recipients at a regional transplant center were recruited during routine outpatient clinic visits in the first month after transplant. Patients with a body mass index >40 kg/m2 or <18.5 kg/m2, severe malnutrition, or ongoing medical complications were excluded. INTERVENTION: Participants were randomized to intensive nutrition intervention (individualized nutrition and exercise counselling; 12 dietitian visits; 3 exercise physiologist visits over 12 months) or to standard nutrition care (guideline based; 4 dietitian visits). MAIN OUTCOME MEASURES: The primary outcome was weight at 6 months after transplant adjusted for baseline weight, obesity, and gender, analyzed using analysis of covariance. The secondary outcomes included body composition, biochemistry, quality of life, and physical function. RESULTS: Thirty-seven participants were randomized to the intensive intervention (n = 19) or to standard care (n = 18); one intensive group participant withdrew before baseline. Weight increased between baseline, 6 and 12 months (78.0 ± 13.7 [standard deviation], 79.6 ± 13.0 kg, 81.6 ± 12.9 kg; mean change 4.6% P < .001) but at 6 months did not differ significantly between the groups: 77.0 ± 12.4 kg (intensive); 82.2 ± 13.4 kg (standard); difference in adjusted means 0.4 kg (95% confidence interval: -2.2 to 3.0 kg); analysis of covariance P = .7. No between-group differences in secondary outcomes were observed. Across the whole cohort, total body protein and physical function (gait speed, sit to stand, grip strength, physical activity, and quality of life [all but 2 domains]) improved. However, adverse changes were seen for total body fat, HbA1c, and fasting glucose across the cohort. CONCLUSIONS: Kidney transplant recipients in the first year after transplant did not benefit from an intensive nutrition intervention compared with standard nutrition care, although weight gain was relatively modest in both groups.

The effect of intensive nutrition interventions on weight gain after kidney transplantation: protocol of a randomised controlled trial.

BACKGROUND: Weight gain and obesity are common after kidney transplantation, particularly during the first year. Obesity is a risk factor for the development of new-onset diabetes after transplantation, and is associated with reduced graft survival. There is a lack of evidence for effective interventions to prevent weight gain after kidney transplantation. METHODS/DESIGN: The effect of INTEnsive Nutrition interventions on weight gain after kidney Transplantation (INTENT) trial is a single-blind (outcomes assessor), randomised controlled trial to assess the effect of intensive nutrition interventions, including exercise advice, on weight gain and metabolic parameters in the first year after transplantation. Participants will be randomised during the first post-transplant month to either standard care (four visits with a renal dietitian over twelve months) or intensive nutrition intervention (eight visits with a renal dietitian over the first six months, four visits over the second six months, and three visits over the first six months with an exercise physiologist). In the intensive intervention group, nutrition counselling will be provided using motivational interviewing techniques to encourage quality engagement. Collaborative goal setting will be used to develop personalised nutrition care plans. Individualised advice regarding physical activity will be provided by an exercise physiologist. The primary outcome of the study is weight at six months after transplant, adjusted for baseline (one month post-transplant) weight, obesity and gender. Secondary outcomes will include changes in weight and other anthropometric measures over 12 months, body composition (in vivo neutron activation analysis, total body potassium, dual-energy X-ray absorptiometry, and bioelectrical impedance), biochemistry (fasting glucose, lipids, haemoglobin A1c and insulin), dietary intake and nutritional status, quality of life, and physical function. DISCUSSION: There are currently few randomised clinical trials of nutrition interventions after kidney transplantation. The INTENT trial will thus provide important data on the effect of intensive nutrition interventions on weight gain after transplant and the associated metabolic consequences. Additionally, by assessing changes in glucose metabolism, the study will also provide data on the feasibility of undertaking larger multi-centre trials of nutrition interventions to reduce the incidence or severity of diabetes after transplantation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number: ACTRN12614000155695.

Total laparoscopic distal pancreatectomy: beyond selected patients.

Laparoscopic distal pancreatectomy (LDP) has emerged as the procedure of choice for selected patients. This study is to evaluate the feasibility of LDP and procedural outcomes in a series of consecutive nonselected patients. All patients undergoing distal pancreatectomy over 18 months were identified from a prospectively maintained database, under institutional review board approval. A completely laparoscopic (non hand-assisted) procedure was performed using a 4-trocar technique. Conversion to an open procedure, operative time (OR), estimated blood loss (EBL), transfusion requirements, postoperative length of stay (LOS), and complications were assessed. Sixteen patients were identified; 2/16 patients had undergone distal pancreatectomy as a component of another multiorgan open procedure, and were thus excluded. The remaining 14 patients had consented for LDP. Conversion occurred in 4/14 cases. Converted patients trended towards increased OR, EBL, and LOS (P = not significant). No mortalities occurred, and overall morbidities included: pancreatic fistula (n = 2), splenic abscess (n = 1), and pneumonia (n = 1). LDP-splenectomy (n = 3/14) was associated with both increased EBL (683 mL ± 388 vs 168 ± 141, P < 0.002) and increased transfusion rate (3/3 vs 3/11, P = 0.05), as compared with LDP-splenic preservation. LDP with splenic artery preservation (LDP-SAP) was completed in 7 of 14 patients, with less OR (2 hours 29 minutes ± 53 minutes vs 3 hours 40 minutes ± 1 hour, P < 0.05), a decreased transfusion rate (14% vs 71%, P = 0.05), and decreased LOS (2.8 days vs 6.8 days, P = 0.002) compared with LDP without SAP. Pathology was intraductal papillary mucinous neoplasm (IPMN) (n = 5), ductal carcinoma (n = 3), high grade dysphasia (n = 2), neuroendocrine tumor (n = 2), and pancreatitis (n = 2). Patients undergoing LDP-SAP demonstrated superior peri-procedural outcomes. This series of nonselected consecutive patients supports that LDP is technically feasible with a comparable procedural outcome to the selected-patient literature, suggesting potentially expanded indications for LDP.

Obstructive jaundice expands intrahepatic regulatory T cells, which impair liver T lymphocyte function but modulate liver cholestasis and fibrosis.

Although obstructive jaundice has been associated with a predisposition toward infections, the effects of bile duct ligation (BDL) on bulk intrahepatic T cells have not been clearly defined. The aim of this study was to determine the consequences of BDL on liver T cell phenotype and function. After BDL in mice, we found that bulk liver T cells were less responsive to allogeneic or syngeneic Ag-loaded dendritic cells. Spleen T cell function was not affected, and the viability of liver T cells was preserved. BDL expanded the number of CD4(+)CD25(+)Foxp3(+) regulatory T cells (Treg), which were anergic to direct CD3 stimulation and mediated T cell suppression in vitro. Adoptively transferred CD4(+)CD25(-) T cells were converted into Treg within the liver after BDL. In vivo depletion of Treg after BDL restored bulk liver T cell function but exacerbated the degrees of inflammatory cytokine production, cholestasis, and hepatic fibrosis. Thus, BDL expands liver Treg, which reduce the function of bulk intrahepatic T cells yet limit liver injury.

Knowledge of mathematical equivalence in children with specific language impairment: insights from gesture and speech.

PURPOSE: This study investigated understanding of mathematical equivalence in children with and without specific language impairment (SLI). METHOD: A total of 34 children (ages 8;1 [years;months] to 11;7), including 9 with expressive SLI (E-SLI), 8 with expressive and receptive SLI (ER-SLI), and 17 age-matched typically developing (TD) children completed addition and mathematical equivalence problems. The problem-solving strategies revealed in solutions and in gestural and verbal explanations were coded. RESULTS: The children with SLI were less accurate than their TD peers in solving addition and equivalence problems. None of the children in the ER-SLI group solved the equivalence problems correctly; however, the number of children who solved any of the equivalence problems correctly did not differ in the E-SLI and CA groups. Children in the ER-SLI group tended to express incorrect strategies for solving the equivalence problems in both gesture and speech, whereas children in the E-SLI group often expressed correct strategies in gestures, but incorrect strategies in speech. CONCLUSION: Children with SLI showed delays in their knowledge of mathematical equivalence. Children with ER-SLI displayed greater delays than children with E-SLI. Children with E-SLI sometimes expressed more advanced knowledge in gestures, suggesting that their knowledge is represented in a nonverbal format.

Gesture-speech integration in narrative: Are children less redundant than adults?

Speakers sometimes express information in gestures that they do not express in speech. In this research, we developed a system that could be used to assess the redundancy of gesture and speech in a narrative task. We then applied this system to examine whether children and adults produce non-redundant gesture-speech combinations at similar rates. The coding system was developed based on a sample of 30 children. A crucial feature of the system is that gesture meanings can be assessed based on form alone; thus, the meanings speakers express in gesture and speech can be assessed independently and compared. We then collected narrative data from a new sample of 17 children (ages 5-10), as well as a sample of 20 adults, and we determined the average proportion of non-redundant gesture-speech combinations produced by individuals in each group. Children produced more non-redundant gesture-speech combinations than adults, both at the clause level and at the word level. These findings suggest that gesture-speech integration is not constant over the life span, but instead appears to change with development.