Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) - design and rational of a randomized controlled trial.

BACKGROUND: Graft-versus-host disease (GvHD) remains a major complication and limitation to successful allogeneic hematopoietic stem cell transplantation. Treatment of GvHD is challenging due to its heterogeneous nature of presentation, with steroids remaining the established first-line treatment. Long-term doses of systemic corticosteroids have many well-known side-effects including muscle atrophy. Despite the fact that reports in non-cancer clinical populations treated with glucocorticoids demonstrated that resistance training can reverse atrophy and weakness, no RCT has evaluated the potential of resistance training on preventing the disease- and treatment-induced loss of skeletal muscle mass and function in GvHD patients yet. In this context, ensuring adequate nutrition is important as protein deprivation may accelerate the wasting process. As GvHD patients are commonly found to be malnourished, nutritional medical care should be considered when investigating the effect of exercise in GvHD patients. Therefore, the aim of the present "Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD" - Study (IRENE-G) is to evaluate the effects of resistance exercise in combination with nutritional endorsement on physical, nutritional and patient-reported outcomes in GvHD patients. METHODS: IRENE-G is a 24-week prospective interventional RCT. One hundred twelve participants will be randomly allocated (1:1) to one of two arms: resistance exercise and nutritional optimization (experimental) vs. nutritional optimization only (control). Participants in the experimental group will engage in a supervised, progressive moderate-to-high intensity resistance training that is consistent with exercise guidelines for cancer patients, while additionally receiving nutritional support/therapy. Subjects of the control group solely receive nutritional support/therapy based on individual needs. Participants will be assessed at baseline, at 8, 16, 24 weeks for physical performance and various physiological, nutritional and patient-reported outcomes. Follow-up will be 6 months after intervention completion. DISCUSSION: To our knowledge, this will be the first RCT to assess and compare the effects of a resistance intervention supplemented by nutritional support/therapy against nutritional support only on various health-related outcomes in GvHD patients. The study will contribute to our understanding of the value of exercise and nutritional endorsement in counteracting the negative consequences of GvHD and its treatment. TRIAL REGISTRATION: ClinicalTrials.gov : NCT05111834 . Registered 8 November 2021 - Retrospectively registered.

Obesity surgery in patients with end-stage organ failure: Is it worth it?

BACKGROUND: Little is known about the long-term outcomes of patients with end-stage organ failure (ESOF) undergoing obesity surgery. OBJECTIVE: To investigate the perioperative and mid-term outcomes of patients with ESOF undergoing obesity surgery. SETTING: University hospital, Germany. METHODS: A total of 1 094 patients undergoing obesity surgery from 2006 to 2019 were screened. Inclusion criteria were ejection fraction <30%, continuous oxygen/noninvasive ventilation therapy, liver cirrhosis, or kidney failure stage 4/5. ESOF patients were compared with matched standard (MS) patients without advanced organ failure and matched for age, gender, body mass index (BMI), operation type, diabetes, arterial hypertension, and sleep apnea. RESULTS: Twenty-seven ESOF patients (56% female, age 50.3 ± 8.6, BMI 53.8 ± 8.7 kg/m2) were identified. Eighty-five percent had a sleeve gastrectomy. Mid-term total weight loss was 26.6% ± 9.0% in the ESOF patients versus 17.8% ± 11.1% in MS patients (P = .181). Long-term improvement of type 2 diabetes was comparable (ESOF: HbA1C 8.79 ± 2.06% to 6.25±1.17%, P = .047; MS: HbA1C 7.94 ± 2.02% to 7.2 ± 1.28%; P = .343). Depression scores (Patient Health Questionnaire 9) among ESOF patients improved from 13.0 ± 6.3 to 6.1 ± 5.8 (P = .004) but without significant change in MS patients (9.4 ± 7.3 to 4.3 ± 5.7; P = .082). Lung function improved in all patients although only 15% were off oxygen therapy. Treatment goals were achieved in >50% of the other groups. Major complications occurred in 11% (ESOF) versus 4% (MS) of patients (P = .299) with one death in the ESOF group (4%). CONCLUSION: Both groups had similar outcomes regarding weight loss and co-morbidity improvement. Depression only improved significantly in the ESOF group. Patients with ESOF should not be precluded from obesity surgery. Further investigation is needed to define optimized selection criteria.

Is there a Reason Why Obese Patients Choose Either Conservative Treatment or Surgery?

BACKGROUND: The effects of bariatric surgery on excess weight loss (EWL) and comorbidities are proven. Still, a significant number of patients prefer conservative therapy (ConsP). OBJECTIVES: The goal of this study was to examine why ConsP and patients awaiting bariatric surgery (SurgP) choose which therapy, and to define the differences in their expectations. SETTING: Prospective study, 1 university hospital, 1 general hospital, Germany. METHODS: ConsP and SurgP were asked to complete a questionnaire. Statistical analysis including all patients and a BMI-matched cohort was performed using the chi-square and Wilcoxon rank-sum test. RESULTS: Overall, 151 patients participated in this study (50 ConsP, 101 SurgP, 69.4% females). The mean age was 41.1 years (SD ± 12.2 years). ConsP had a significant lower body mass index (BMI, 44.7 kg/m2 vs. 49.3 kg/m2, p < 0.01). The educational level was significantly higher in ConsP. SurgP suffered significantly more often from depression (21.6% vs. 36.6%, p = 0.02) and joint pain (45.1% vs. 68.7%, p = 0.02). ConsP completed significantly more diets that were supervised by physicians or considered well-structured (56.3% vs. 31.0%, p = 0.04). SurgP considered their chosen therapy a last resort significantly more often (p < 0.01). A BMI-matched analysis between ConsP and SurgP revealed no significant differences in the prevalence of comorbidities but showed that fear of surgery plays a major role in the decision-making processes of obese patients. CONCLUSION: A higher BMI and a greater prevalence of comorbidities had driven patients to seek a more radical solution for their obesity, i.e., surgery. The BMI-matched analysis suggests that fear of surgery is a relevant factor in why obese patients do not decide to undergo bariatric surgery lightly.

The effect of lifestyle intervention in obesity on the soluble form of activated leukocyte cell adhesion molecule.

BACKGROUND: The aim of this study was to investigate the effect of a lifestyle intervention in obesity on the soluble form of the activated leukocyte cell adhesion molecule (sALCAM) and its association with metabolic parameters. METHODS: Twenty-nine obese subjects selected from the OPTIFAST®52 program. This program consisted into 2 crucial phases: an initial 12-week active weight reduction phase, followed by a 40-week weight maintenance phase. At baseline, after 12 weeks and at the end of the program, fasting glucose and insulin, total cholesterol, LDL-C, HDL-C, triglycerides, adiponectin, leptin, high sensitivity CRP, sALCAM, homeostasis model assessment-estimated insulin resistance (HOMA-IR) and leptin-to-adiponectin-ratio were determined. Oral glucose tolerance test (OGTT) was performed when indicated. RESULTS: At baseline, the serum concentration of sALCAM was increased and correlated positively with HOMA-IR and negatively with age. At the end of the program, sALCAM concentrations decreased significantly. Multivariate analysis showed that sALCAM significantly correlated with age, glucose concentration after 2 h OGTT and the HOMA-IR. A higher decrease of HOMA-IR during the study was observed in subjects with higher concentration of sALCAM at baseline. CONCLUSIONS: sALCAM might be a novel biomarker in obesity that correlates and predicts insulin sensitivity improvement and that can be affected by lifestyle intervention.

Risk of Malnutrition, Trace Metal, and Vitamin Deficiency Post Roux-en-Y Gastric Bypass--a Prospective Study of 20 Patients with BMI < 35 kg/m².

BACKGROUND: Due to its reliable effects on type 2 diabetes mellitus (T2DM) remission, Roux-en-Y gastric bypass (RYGB) has recently been investigated as a treatment option for nonseverely obese patients with T2DM (body mass index (BMI) <35 kg/m(2)). The purpose of this study was to investigate whether RGYB induces malnutrition of macro- and micronutrients within 24 months in these patients. METHODS: A prospective cohort of 20 patients with longstanding, insulin-dependent T2DM and a BMI of 25-35 kg/m(2) were treated with RYGB. The patients were supplemented with over-the-counter, multivitamin, and micronutrient supplements. Serum concentrations of albumin, vitamins, and trace elements, hemoglobin, and bone density were measured preoperatively and over a 24-month period (DRKS00004605). RESULTS: RYGB did not result in underweight or protein malnutrition. No new onset of deficiencies of water- or fat-soluble vitamins developed over the study period. However, serum selenium, zinc, and ferritin decreased significantly (selenium, 1.17 ± 0.13 to 0.89 ± 0.11 µmol/l, p = 0.018; zinc, 13.9 ± 0.5 to 10.8 ± 0.5 µmol/l, p = 0.012; ferritin, 171.7 ± 26.9 to 31.8 ± 11.2 µg/l, p = 0.018). Hemoglobin remained stable. Vitamin D (13.7 ± 1.8 to 19.1 ± 1.1 ng/ml, p = 0.017) and osteocalcin (15.3 ± 1.7 to 25.4 ± 2.7 ng/ml, p = 0.025) rose significantly, whereas the parathyroid hormone remained stable. Despite increased bone formation, bone density decreased (T score hip, 0.15 ± 0.25 to -0.71 ± 0.34, p = 0.005) resulting in a significant increase in osteopenia rates (18 to 50 %, p = 0.046). CONCLUSIONS: This is the first prospective cohort to investigate malnutrition after RYGB in nonseverely obese patients. These patients are at risk of developing iron, selenium, and zinc deficiencies within 24 months, as well as osteopenia despite an increase in bone formation.

Translation and validation of the German version of the weight self-stigma questionnaire (WSSQ).

The experience of stigmatization is widespread among obese patients. The aim of the present study was to translate the English version of the weight self-stigma questionnaire (WSSQ) into German and to evaluate the psychometric properties of the German version in a sample of severely obese persons. Between March and June 2013, in the Outpatient Department of Obesity, University Hospital Heidelberg, 94 obese patients were recruited consecutively. A comprehensive questionnaire was completed by the participants. Significant correlations between WSSQ scores and mental quality of life, weight-related quality of life, depression, shame, guilt, and psychological distress all demonstrated the construct validity of the German version of the WSSQ. Patients with a BMI ≥ 50 showed a significantly higher self-stigma compared to patients with a BMI between 35 and 50.

Indications for intestinal transplantation: recognizing the scope and limits of total parenteral nutrition.

Total parenteral nutrition (TPN) is currently the treatment of choice for patients with intestinal failure. Intestinal failure in adults is mostly due to short bowel syndrome, which is most often caused by ischemia and Crohn's disease. However, TPN fails in a substantial number of cases. For patients with TPN failure, intestinal transplantation (ITx) may be offered as a treatment. TPN failure is considered to be present either if nutrition itself is not possible or if complications of TPN occur. These complications can, for example, originate from recurrent line infections or thrombosis. As TPN is usually a lifelong therapy and is associated with substantial impairment of the quality of life, the tolerance of each patient to this procedure is another important consideration in the decision making about whether to perform transplantation. The survival rates of intestinal transplant recipients have now reached the same level as that of recipients of other solid organ transplants. A five-yr survival of up to 80% has been reported in specialized centers, whereas registry data show rates of <80%. Although in about one-third of patients, isolated ITx is sufficient, patients with concurrent liver disease (mostly due to TPN) benefit from combined intestinal and liver transplantation. In some cases, multivisceral transplantation is necessary. Here, we review the current indications for ITx with a special focus on TPN.