Fibromyalgia (FM) is characterized by widespread pain and fatigue and is considered a syndrome with different pathogenic mechanisms. Controversial data on GH axis disturbances have been published. Some preliminary trials have shown promising effects of GH therapy on tender points and quality of life in FM. The aim was to study the patterns of GH secretion/sensitivity in a cohort of severe FM patients. The study was conducted in five tertiary hospitals. A total of 493 FM women (1990 American College of Rheumatology criteria) recruited from five centers, having more than 16 tender points, Fibromyalgia Impact Questionnaire scores above 75, more than 1 yr of stable medication (serotonin reuptake inhibitors, amitriptyline, and opioids), and body mass index below 35 kg/m(2) underwent baseline IGF-I/GH determinations; an insulin tolerance test (ITT) and a modified IGF-I generation test were performed in those cases showing IGF-I of 150 microg/liter or less. A total of 169 of the 493 patients (34.2%) showed IGF-I of 150 microg/liter or less. Mean peak GH during ITT was 13.3 +/- 9.9 ng/ml in 127 patients in which the test was performed. In 22 of 127 (17.3%), ITT peak GH was 5 microg/ml or less, and in eight of them (6.3%), the peak GH was 3 ng/ml or less. Mean baseline GH (n = 127) was 1.47 +/- 2.58 ng/dl, and eight of 120 (6.8%) showed an insufficient IGF-I response (<50% over baseline) to the IGF-I generation test. FM patients show a high prevalence of GH axis dysfunction. A significant number of patients show biochemical patterns of GH deficiency as well as some degree of GH resistance and might be potential candidates for substitution treatment.

Summary: Objective: Abdominal fat ultrasound (US) is a simple clinical tool that may allow measures of fat depots not visible using common dual‐energy X‐ray absorptiometry (DEXA) or computerized tomography (CT) imaging. The aim of this study was to validate the technique, give measures of superficial and profound subcutaneous, preperitoneal, omental and perirenal (retroperitoneal) fat and correlate them with MS markers.Methods: Sequential US measures of these five abdominal fat layers were done at 397 adults. Blood pressure (BP), body mass index (BMI), waist, body fat %, HOMA‐IR index (homeostatic model assessment of insulin resistance), lipid profile and leptin were recorded. Metabolic syndrome (MS) was defined according to Cholesterol education programme adult treatment panel III (ATPIII) criteria.Results: Subcutaneous and omental fat were increased among people with obesity, whereas preperitoneal and perirenal fat did not show any difference according to BMI or waist. Women showed thicker subcutaneous fat (both superficial and profound), whereas men had bigger omental fat. Both postmenopausal and diabetic patients had changes in omental fat only, whereas patients with fatty liver showed thicker preperitoneal and perirenal fat, as well. MS patients showed both thicker perirenal and omental fat. A cut‐off of 54 mm in male (M)/34 mm in female (F) of omental fat and 22.5 mm (M)/12.5 mm (F) of perirenal fat could be predictive of later MS onset.Conclusions: US is a valid method to measure all different abdominal fat depots. Omental and perirenal fat measures may classify patients at risk for MS. Preperitoneal fat depot may also correlate with fatty liver disease.

Functional defects in growth hormone (GH) secretion and its efficacy as a complementary treatment have been suggested for fibromyalgia. This study investigated the efficacy and safety of low-dose GH as an add-on therapy in patients with both severe FM and low insulin-like growth factor 1 levels. A total of 120 patients were enrolled in a multicenter, placebo-controlled study for 18 months. They were randomly assigned to receive either 0.006 mg/kg/day of GH subcutaneously (group A, n=60) or placebo (group B, n=60) for 6 months (blind phase). The placebo arm was switched to GH treatment from month 6 to month 12 (open phase), and a follow-up period after GH discontinuation was performed until month 18. Standard treatment for fibromyalgia (selective serotonin re-uptake inhibitors, opioids, and amitriptyline) was maintained throughout the study. Number and intensity of tender points, Fibromyalgia Impact Questionnaire (FIQ) with its subscales, and EuroQol 5 dimensions test (EQ5D) with visual analogue scale (VAS) were assessed at different time points. At the end of the study, 53% of group A patients obtained fewer than 11 positive tender points, vs 33% of group B patients (P<.05). 39.1% vs 22.4% reached more than 50% improvement in VAS (P<.05). Group A patients showed significantly improved FIQ scores (P=.01) compared with group B. Although GH discontinuation worsened all scores in both groups during follow-up, impairment in pain perception was less pronounced in the GH-treated group (P=.05). In this largest and longest placebo-controlled trial performed in FM (NCT00933686), addition of GH to the standard treatment is effective in reducing pain, showing sustained action over time.

Background: The use of apps to tackle overweight and obesity by tracking physical and dietary patterns and providing recommendations and motivation strategies to achieve personalized goals has increased over recent years. However, evidence of the efficacy, effectiveness, and safety of these apps is severely lacking. Objective: The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile health (mHealth) interventions through a systematic review. Methods: PubMed, PsycINFO, Scopus, UK Trial Database, ClinicalTrials.gov, and the Cochrane Library were surveyed up to May 2018. All types of clinical studies were considered. A total of 2 independent reviewers assessed quality using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Ratings were used to provide an overall score for each study (low, moderate, or high). Data were synthesized in evidence tables. Results: From 233 potentially relevant publications, only 28 studies were included. Of these, 13 (46%) were randomized control trials, 11 were single-arm studies (39%), 3 were nonrandomized controlled trials (11%), and 1 study was a cluster randomized trial (4%). The studies were classified as low (15), high (7), and moderate (6) quality according to SIGN criteria. All studies focused on efficacy, with only 1 trial mentioning safety and another 1 effectiveness. In 11 studies, the apps were used as stand-alone interventions, the others were multicomponent studies that included other tools for support such as sensors or websites. The main management tool included in the apps was feedback messaging (24), followed by goal-setting mechanisms (20) and self-monitoring (19). The majority of studies took weight or body mass index loss as the main outcome (22) followed by changes in physical activity (14) and diet (12). Regarding outputs, usability, adherence, and engagement (17) were the most reported, followed by satisfaction (7) and acceptability (4). Conclusions: There is a remarkable heterogeneity among these studies and the majority have methodological limitations that leave considerable room for improvement. Further research is required to identify all relevant criteria for assessing the efficacy of mHealth interventions in the management of overweight and obesity. Trial Registration: PROSPERO CRD42017056761; https://tinyurl.com/y2zhxtjx

Sodium-glucose co-transporters type 2 inhibitors (SLGT2i) are highly effective in controlling type 2 diabetes, but reported beneficial cardiovascular effects suggest broader actions on insulin resistance. Weight loss may be initially explained by glycosuria-induced net caloric output and secondary volumetric reduction, but its maintenance could be due to loss of visceral fat mass. Structured ultrasound (US) imaging of abdominal adipose tissue (“eco-obesity”) is a recently described methodology used to measure 5 consecutive layers of abdominal fat, not assessable by DEXA or CT scan: superficial subcutaneous (SS), deep subcutaneous (DS), preperitoneal (PP), omental (Om) and right perirenal (RK). PP, Om and RK are predictors of metabolic syndrome (MS) with defined cut-off points. To assess the effect of SLGT2i on every fat depot we enrolled 29 patients with type 2 Diabetes (HbA1c 6.5–9%) and Obesity (IMC > 30 kg/m²) in an open-label, randomized, phase IV trial (EudraCT: 2019-000979-16): the Omendapa trial. Diabetes was diagnosed < 12 months before randomization and all patients were treatment naïve. 14 patients were treated with metformin alone (cohort A) and 15 were treated with metformin + dapaglifozin (cohort B). Anthropometric measures and laboratory tests for glucose, lipid profile, insulin, HOMA, leptin, ultrasensitive-CRP and microalbuminuria (MAL) were done at baseline, 3rd and 6th months. At 6th month, weight loss was −5.5 ± 5.2 kg (5.7% from initial weight) in cohort A and −8.4 ± 4.4 kg (8.6%) in cohort B. Abdominal circumference showed a −2.7 ± 3.1 cm and −5.4 ± 2.5 cm reduction, respectively (p = 0.011). Both Metformin alone (−19.4 ± 20.1 mm; −21.7%) or combined with Dapaglifozin (−20.5 ± 19.4 mm; −21.8%) induced significant Om fat reduction. 13.3% of cohort A patients and 21.4% of cohort’s B reached Om thickness below the cut-off for MS criteria. RK fat loss was significantly greater in cohort B group compared to cohort A, at both kidneys. Only in the Met + Dapa group, we observed correlations between Om fat with leptin/CRP/MAL and RK fat with HOMA-IR. US is a useful clinical tool to assess ectopic fat depots. Both Metformin and Dapaglifozin induce fat loss in layers involved with MS but combined treatment is particularly effective in perirenal fat layer reduction. Perirenal fat should be considered as a potential target for cardiovascular dapaglifozin beneficial effects.

Background: The use of apps for weight management has increased over recent years; however, there is a lack of evidence regarding the efficacy and safety of these apps. The EVALAPPS project will develop and validate an assessment instrument to specifically assess the safety and efficacy of weight management apps. Objective: The aim of this study was to reach a consensus among stakeholders on a comprehensive set of criteria to guide development of the EVALAPPS assessment instrument. A modified Delphi process was used in order to verify the robustness of the criteria that had been identified through a literature review and to prioritize a set of the identified criteria. Methods: Stakeholders (n=31) were invited to participate in a 2-round Delphi process with 114 initial criteria that had been identified from the literature. In round 1, participants rated criteria according to relevance on a scale from 0 (“I suggest this criterion is excluded”) to 5 (“This criterion is extremely relevant”). A criterion was accepted if the median rating was 4 or higher and if the relative intraquartile range was equal to 0.67 or lower. In round 2, participants were asked about criteria that had been discarded in round 1. A prioritization strategy was used to identify crucial criteria according to (1) the importance attributed by participants (criteria with a mean rating of 4.00 or higher), (2) the level of consensus (criteria with a score of 4 or 5 by at least 80% of the participants). Results: The response rate was 83.9% (26/31) in round 1 and 90.3% (28/31) in round 2. A total of 107 out of 114 criteria (93.9%) were accepted by consensus—105 criteria in round 1 and 2 criteria in round 2. After prioritization, 53 criteria were deemed crucial. These related mainly to the dimensions of security and privacy (13/53, 24.5%) and usability (9/53, 17.0%), followed by activity data (5/53, 9.4%), clinical effectiveness (5/53, 9.4%), and reliability (5/53, 9.4%). Conclusions: Results confirmed the robustness of the criteria that were identified, with those relating to security and privacy being deemed most relevant by stakeholders. Additionally, a specific set of criteria based on health indicators (activity data, physical state data, and personal data) was also prioritized.