Effect of SGLT2 inhibitors on kidney function of type 2 diabetes patients during Ramadan: A systematic review.

Background: SGLT2 inhibitors are known for their osmotic diuretic effect, and their use by Muslim patients with type 2 diabetes during the fasting month of Ramadan may pose an increased risk of volume depletion, potentially impacting renal function. Methods: We conducted a systematic review registered on PROSPERO (registration number CRD42020204582) of studies published between 2013 and January 2023, sourced from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. The study selection criteria included controlled studies that reported the use of SGLT2 inhibitors (SGLT2i) by fasting adult type 2 diabetes patients and provided data on creatinine or estimated glomerular filtration rate (eGFR) as outcomes. Results: Two prospective observational studies, encompassing a total of 359 participants, of which 197 utilized SGLT2 inhibitors, were identified. Our findings indicated that the use of SGLT2 inhibitors during Ramadan did not result in a significant alteration in eGFR. In one study by Hassanein et al., the mean changes in eGFR for the SGLT2i group, as compared to the non-SGLT2i group, were -1.2 ± 19.4 and 3.1 ± 14.8, respectively (p = 0.06). In a study by Shao et al., the least squares mean changes for eGFR in the SGLT2i group, compared to the non-SGLT2i group, were -6.0 ± 1.5 (95% CI, -8.9 to -3.1) and -4.2 ± 1.6 (95% CI, -7.3 to -1.1), respectively (p = 0.39). Conclusion: Despite the limited number of observational studies available, our analysis suggests that the use of SGLT2 inhibitors by type 2 diabetes patients during Ramadan does not appear to significantly impact kidney function.

Effect of SGLT2 inhibitors on kidney function of type 2 diabetes patients during Ramadan: A systematic review.

Background: SGLT2 inhibitors are known for their osmotic diuretic effect, and their use by Muslim patients with type 2 diabetes during the fasting month of Ramadan may pose an increased risk of volume depletion, potentially impacting renal function. Methods: We conducted a systematic review registered on PROSPERO (registration number CRD42020204582) of studies published between 2013 and January 2023, sourced from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. The study selection criteria included controlled studies that reported the use of SGLT2 inhibitors (SGLT2i) by fasting adult type 2 diabetes patients and provided data on creatinine or estimated glomerular filtration rate (eGFR) as outcomes. Results: Two prospective observational studies, encompassing a total of 359 participants, of which 197 utilized SGLT2 inhibitors, were identified. Our findings indicated that the use of SGLT2 inhibitors during Ramadan did not result in a significant alteration in eGFR. In one study by Hassanein et al., the mean changes in eGFR for the SGLT2i group, as compared to the non-SGLT2i group, were -1.2 ± 19.4 and 3.1 ± 14.8, respectively (p = 0.06). In a study by Shao et al., the least squares mean changes for eGFR in the SGLT2i group, compared to the non-SGLT2i group, were -6.0 ± 1.5 (95% CI, -8.9 to -3.1) and -4.2 ± 1.6 (95% CI, -7.3 to -1.1), respectively (p = 0.39). Conclusion: Despite the limited number of observational studies available, our analysis suggests that the use of SGLT2 inhibitors by type 2 diabetes patients during Ramadan does not appear to significantly impact kidney function.

Evolution of gastroesophageal reflux disease symptoms after bariatric surgery: A dose-response meta-analysis.

BACKGROUND: Obesity is associated with increased prevalence of gastroesophageal reflux disease, with recent reports suggesting improvement in gastroesophageal reflux disease symptoms and weight loss following bariatric surgical intervention. However, the exact impact of the type of bariatric surgery on the evolution of gastroesophageal reflux disease symptoms has remained unexamined. METHODS: We systematically searched electronic databases (PubMed, EMBASE, Web of Science, and the Cochrane Library from inception to December 2018) for eligible studies that satisfy prespecified inclusion criteria. We included clinical trials of all designs that reported on gastroesophageal reflux disease outcomes following laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass. Two independent reviewers extracted relevant data based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Data were pooled using a random-effects model. Main outcomes were symptomatic improvement in gastroesophageal reflux disease symptoms following bariatric surgery. RESULTS: A total of 31 studies were analyzed, and a robust-error meta-regression model was used to conduct a dose-response meta-analysis synthesizing data on 31 studies that reported gastroesophageal reflux disease outcomes after bariatric surgery. Of 5,295 patients who underwent either laparoscopic sleeve gastrectomy (n = 4,715 patients) or laparoscopic Roux-en-Y gastric bypass (n = 580 patients), 63.4% experienced improvement in gastroesophageal reflux disease symptoms (95% CI 32.46-72.18). The dose-response meta-analysis demonstrated a window period of 2 years for sustained improvement after which symptoms began to recur in those that were asymptomatic. CONCLUSION: Bariatric surgery may improve gastroesophageal reflux disease symptoms in obese patients who underwent laparoscopic sleeve gastrectomy; however, the most favorable effect is likely to be found after Roux-en-Y gastric bypass surgery. The effects were not sustained and returned to baseline within 4 years.

Myxedema Psychosis: Systematic Review and Pooled Analysis.

BACKGROUND AND OBJECTIVE: The term myxedema psychosis (MP) was introduced to describe the occurrence of psychotic symptoms in patients with untreated hypothyroidism, but the optimal assessment and treatment of this condition are unclear. We aimed to synthesize data from the literature to characterize the clinical presentation and management of MP. METHODS: We performed a systematic review according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines in PubMed (Medline), Embase, Google Scholar, and Cochrane databases, including observational studies, case series, and case reports published from 1/1/1980 to 31/12/2019 in the English language. Descriptive statistics along with univariate and multivariate analysis were used for data synthesis. RESULTS: Out of 1583 articles screened, 71 case reports met our inclusion criteria providing data on 75 MP cases. The median age at diagnosis was 42 years [32-56]. About 53% had no prior hypothyroidism diagnosis. Delusions occurred in 91%, with a predominance of persecutory ideas (84%), while hallucinations occurred in 78%. Physical symptoms and signs of hypothyroidism were absent in 37% and 26%, respectively. If symptoms occurred, nonspecific fatigue was seen most frequently (63%). The median thyroid-stimulating hormone value was 93 mIU/L [60-139]. Thyroid peroxidase antibodies were found positive in 75% (23/33) of reported cases. Creatinine kinase was reported abnormal in seven cases. Cranial imaging (CT or MRI) and electroencephalogram were normal in 89%, 75%, and 73% of the cases reported. The majority of patients were treated orally with thyroxine in combination with short-term antipsychotics. More than 90% of them showed complete recovery. Univariate analysis revealed a trend towards a shorter duration of psychosis with IV thyroid hormone therapy (p= 0.0502), but the effect was not consistent in a multivariate analysis. CONCLUSION: While we identified a substantial lack of published research on MP, our pooled analysis of case observations suggests that the condition presents a broad spectrum of psychiatric and physical symptoms lending support to the value of screening for thyroid dysfunction in patients with first-ever psychosis. PROSPERO REGISTRATION NUMBER: CRD42020160310.

Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial.

BACKGROUND: Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. However, individual fluid needs differ between patients due to varying degrees of systemic vasodilation, circulatory flow maldistribution, and increased vascular permeability. The current fluid resuscitation practice has been questioned. Fluid overload is associated with higher mortality in sepsis. A sign of fluid overload is extravascular lung water, seen as B lines in lung ultrasound. B lines correlate inversely with oxygenation (measured by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen ie, PaO2/FiO2). Thus, B lines seen by bedside ultrasound may have a role in guiding fluid therapy. OBJECTIVE: We aim to evaluate if fluid administration guided by lung ultrasound in patients with sepsis in emergency departments will lead to better oxygenation and patient outcomes than those in the standard therapy. METHODS: A phase II, multicenter, randomized, open-label, parallel-group, superiority trial will be performed. Patients will be recruited at emergency departments of the participating centers. A total of 340 patients will be randomly allocated to the intervention or standard-of-care group (30mL/kg). The intervention group will receive ultrasound-guided intravenous fluid until 3 B lines appear. The primary outcome will be oxygenation (measured as PaO2/FiO2 ratio) at 48 hours after starting intravenous fluid administration. Secondary outcomes will be patients' outcome parameters, including oxygenation after 15 mL/kg fluid at 6, 12, 24, and 48 hours; sepsis progress through Sequential Organ Failure Assessment (SOFA) scores; pulmonary edema evaluation; and 30-day mortality. RESULTS: The trial will be conducted in accordance with the Declaration of Helsinki. Institutional review board approval will be sought after the participating sites are selected. The protocol will be registered once the institutional review board approval is granted. The trial duration is expected to be 1.5-2.5 years. The study is planned to be performed from 2021 to 2022, with enrollment starting in 2021. First results are expected in 2022. Informed written consent will be obtained before the patient's enrollment in the study. An interim analysis and data monitoring will ensure the patient safety. The results will be published in a peer-reviewed journal and discussed at international conferences. CONCLUSIONS: This is a protocol for a randomized control trial that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B lines evaluation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15997.

Myxedema psychosis: A protocol for a systematic review and a pooled analysis.

BACKGROUND: Myxedema psychosis (MP) is a rare presentation of hypothyroidism. Although known for >70 years, a significant lack of systematic literature describing this condition exists. This limits the clinician's ability to identify and manage this entity properly. Hence, we aimed to systematically review the literature and summarize the presentation, diagnosis, management, and outcomes of this rare entity. METHODS: Systematic review following PRISMA guidance. We will perform a comprehensive search of PubMed, Medline, Embase, Google Scholar (first 300 hits), and Cochrane databases for published observational studies, case series, and case reports. We will use descriptive statistics to provide summary estimates of demographics, common presenting features, laboratory test results, imaging findings, treatment administered, and outcomes. Moreover, continuous variables will be compared by the Wilcoxon Mann Whitney test, whereas categorical variables will be assessed by the χ test. Bivariate and multivariate regression will be performed to assess risk factors associated with poor outcome. A scoping review revealed that a meta-analysis might not be feasible owing to the paucity of systematic studies describing the condition. RESULTS: This is the first systematic review examining this rare entity. Thus, the result of which will be significant. We hope that this review will help in identifying relevant predictive clinical or laboratory characteristics. Additionally, it identifies the best treatment strategies. The findings of this review will help increase our knowledge of this condition so as to recognize this condition promptly. Also, it will assist in differentiating MP from masqueraders, such as Hashimoto encephalopathy (HE). The results of this review will be published in a peer-reviewed journal. CONCLUSION: This is the first systematic review exploring MP demographics, diagnosis treatment, and outcomes. The information gathered by this review will be necessary for patients, clinicians, researchers, and guideline makers. PROSPERO REGISTRATION NUMBER: CRD42020160310.

GERD outcome after bariatric surgery: A protocol for systematic review and meta analysis.

BACKGROUND/AIM: Obesity is associated with increased incidence of gastroesophageal reflux disease (GERD), and it has been suggested that GERD symptoms may be improved by weight reduction. However, various patterns of bariatric surgery may affect symptoms of GERD due to the changed anatomy of stomach and esophagus. The aim of this systematic review and meta-analysis is to analyze the effect of bariatric surgery on GERD. MATERIALS AND METHODS: A systematic literature search was performed using PubMed, EMBASE, and the Cochrane Library from January 2005 to January 2019, combining the words obesity, gastroesophageal reflux with different types of bariatric surgery and weight loss. The methodological quality of randomized controlled trials and non-randomized controlled trials published in English and have at least 1-year follow-up data were included and assessed by Cochrane Collaboration's tool for assessing risk bias and Newcastle-Ottawa scale. Only clinical trials were included, and case series or case reports were excluded. RESULTS: We anticipate that our review will provide the exact estimates of the burden and phenotype of GERD among patients that have undergone bariatric surgery. CONCLUSION: GERD may improve in obese patients who underwent laparoscopic sleeve gastrectomy (LSG); however, the most favorable effect is likely to be found after Roux-en-Y gastric bypass surgery. PROSPERO REGISTRATION NUMBER: CRD42018090074.