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Background: Obesity is a global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass are effective but accompanied by risk of serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown to be superior to a sham procedure.
Methods: We designed a multi-center, randomized, patient and assessor-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities and indication for proton pump inhibitors are randomized to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). All participants undergo regular dietary consultation. The IB will be removed after 6 months, whereas the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in comorbidities, quality of life, complication rates and safety will be evaluated.
Discussion: This trial could help to identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment.
Trial registration: 16th January 2017. DRKS00011036. Funded by the German Research Foundation (DFG).
Many sports employ caloric restriction (CR) to reduce athletes’ body mass. During these phases, resistance training (RT) volume is often reduced to accommodate recovery demands. Since RT volume is a well-known anabolic stimulus, this review investigates whether a higher training volume helps to spare lean mass during CR. A total of 15 studies met inclusion criteria. The extracted data allowed calculation of total tonnage lifted (repetitions × sets × intensity load) or weekly sets per muscle group for only 4 of the 15 studies, with RT volume being highly dependent on the examined muscle group as well as weekly training frequency per muscle group. Studies involving high RT volume programs (≥ 10 weekly sets per muscle group) revealed low-to-no (mostly female) lean mass loss. Additionally, studies increasing RT volume during CR over time appeared to demonstrate no-to-low lean mass loss when compared to studies reducing RT volume. Since data regarding RT variables applied were incomplete in most of the included studies, evidence is insufficient to conclude that a higher RT volume is better suited to spare lean mass during CR, although data seem to favor higher volumes in female athletes during CR. Moreover, the data appear to suggest that increasing RT volume during CR over time might be more effective in ameliorating CR-induced atrophy in both male and female resistance-trained athletes when compared to studies reducing RT volume. The effects of CR on lean mass sparing seem to be mediated by training experience, pre-diet volume, and energy deficit, with, on average, women tending to spare more lean mass than men. Potential explanatory mechanisms for enhanced lean mass sparing include a preserved endocrine milieu as well as heightened anabolic signaling.