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Annals of Surgery Open : Perspectives... Jun 2024To assess the external validity of randomized controlled trials (RCTs) of bariatric surgical treatment on diabetes control.
OBJECTIVE
To assess the external validity of randomized controlled trials (RCTs) of bariatric surgical treatment on diabetes control.
BACKGROUND
Multisite RCTs provide the strongest evidence supporting clinical treatments and have the greatest internal validity. However, characteristics of trial participants may not be representative of patients receiving treatment in the real world. There is a need to assess how the results of RCTs generalize to all contemporary patient populations undergoing treatments.
METHODS
All patients undergoing sleeve gastrectomy at University of California Los Angeles (UCLA) between January 8, 2018 and May 19, 2023 had their baseline characteristics, weight change, and diabetes control compared with those enrolled in the surgical treatment and medications potentially eradicate diabetes efficiently (STAMPEDE) and diabetes surgery study (DSS) RCTs of bariatric surgery's effect on diabetes control. Weight loss and diabetes control were compared between UCLA patients who did and did not fit the entry criteria for these RCTs.
RESULTS
Only 65 (17%) of 387 patients with diabetes fulfilled the eligibility criteria for STAMPEDE, and 29 (7.5%) fulfilled the criteria for DSS due to being older, having higher body mass index, and lower HbA1c. UCLA patients experienced slightly less weight loss than patients in the RCTs but had similar diabetes control. The 313 (81%) patients not eligible for study entry into either RCT had similar long-term diabetes control as those who were eligible for the RCTs.
CONCLUSIONS
Even though only a very small proportion of patients undergoing bariatric surgery met the eligibility criteria for the 2 major RCTs, most patients in this contemporary cohort had similar outcomes. Diabetes outcomes from STAMPEDE and DSS generalize to most patients undergoing bariatric surgery for diabetes control.
PubMed: 38911638
DOI: 10.1097/AS9.0000000000000414 -
Integrative Medicine Research Sep 2024Auricular acupuncture (AA) has been widely used in overweight and obesity management due to its safety and effectiveness. The combination of other acupuncture therapies...
Adding thread-embedding acupuncture to auricular acupuncture enhances short-term weight reduction in overweight and obesity: A double-blinded, randomized, sham-controlled trial.
BACKGROUND
Auricular acupuncture (AA) has been widely used in overweight and obesity management due to its safety and effectiveness. The combination of other acupuncture therapies with thread-embedding acupuncture (TEA) has shown enhanced effects. However, there is a lack of evidence regarding AA plus TEA for overweight and obesity. This study was conducted to address this question.
METHODS
A randomized placebo-controlled trial was conducted involving 66 overweight or obese participants, divided into two groups: 33 received AA plus TEA, and 33 received AA plus sham TEA over eight weeks. The primary outcome was body weight (BW) reduction. Secondary outcomes included changes in body mass index (BMI) and waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), food cravings questionnaire-trait-reduced (FCQ-Tr) and food craving visual analog scale (VAS) scores. Safety outcomes were adverse events (AEs).
RESULTS
After eight weeks, BW decreased by a mean (SD) of -4.45 (1.29) kg and -2.05 (1.33) kg in the AA plus TEA and AA plus sham TEA groups, respectively (MD [95 % CI]: 2.40 [1.75; 3.05]). BMI, WC, WHR, and food craving VAS score decreased significantly more in the AA plus TEA group than in the AA plus sham TEA group. No significant differences were found in FCQ-Tr and HC between groups. Seven AEs were recorded that were mild and resolved without treatment.
CONCLUSION
The addition of TEA to AA is a safe and effective management of overweight and obesity. Further studies should incorporate dietary and lifestyle modifications and follow-up after the intervention to assess long-term effectiveness.
TRIAL REGISTRATION
The study protocol had been registered on ClinicalTrials.gov (NCT06091761).
PubMed: 38911552
DOI: 10.1016/j.imr.2024.101050 -
JCEM Case Reports Jun 2024Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the management of type 2 diabetes and obesity. It was the first GLP-1 receptor agonist to be...
Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the management of type 2 diabetes and obesity. It was the first GLP-1 receptor agonist to be approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of obesity. To date, numerous skin adverse reactions to liraglutide have been reported, but data regarding hypersensitivity reactions are scarce, raising concerns about its safety and clinical management. We present the case of a 56-year-old female patient with class 3 obesity who was started on subcutaneous liraglutide (Saxenda) by her endocrinologist. One month after starting the aforementioned treatment, the patient presented well-defined, round, erythematous pruriginous plaques surrounding the injection site, around 24 hours after the drug administration. A liraglutide-induced, delayed-type hypersensitivity reaction was suspected, which could be subsequently confirmed by allergy testing and histopathological study. This paper explores the clinical use of liraglutide, the occurrence of hypersensitivity reactions, diagnosis, management, and implications for future research. Understanding and managing liraglutide hypersensitivity is crucial to ensuring the safety and efficacy of this medication.
PubMed: 38911363
DOI: 10.1210/jcemcr/luae105 -
Severe Hypertriglyceridemia in a Patient With Metabolic Syndrome and Psoriasis on Risankizumab-Rzaa.JCEM Case Reports Jun 2024We report a case of severe hypertriglyceridemia (HTG) complicated by hyperviscosity syndrome as a possible adverse reaction to risankizumab-rzaa in a 49-year-old male...
We report a case of severe hypertriglyceridemia (HTG) complicated by hyperviscosity syndrome as a possible adverse reaction to risankizumab-rzaa in a 49-year-old male with a history of longstanding uncontrolled type 2 diabetes, obesity, and coronary artery disease with prior ST-elevation myocardial infarction. On admission, the patient presented with xanthomatous plaques, chest and epigastric discomfort, and headache. Subsequent blood testing revealed severely elevated triglyceride (TG) levels at 7670 mg/dL (86.59 mmol/L) [reference range: <150 mg/dL; 1.69 mmol/L] and total cholesterol at 934 mg/dL (24.14 mmol/L) [reference range: <200 mg/dL; 5.17 mmol/L]. Triglyceride levels decreased and symptoms resolved with dietary restrictions and plasmapheresis. At follow-up, his TG remained elevated but improved, and he was advised to continue lipid-lowering medications as well as cessation of risankizumab. While the patient presented with high risk factors, we posit that the subacute presentation of severe HTG is a possible result of his recent course of risankizumab-rzaa therapy for management of psoriasis. This is noteworthy as pharmaceutical surveys and clinical trials do not list severe HTG as an adverse effect. Postmarketing surveillance studies are essential to confirm this potential association and monitor drug safety. In summary, this case highlights a possible link between risankizumab and severe HTG, emphasizing the importance of ongoing pharmacovigilance to identify and manage unexpected adverse effects associated with new medications.
PubMed: 38911361
DOI: 10.1210/jcemcr/luae087 -
Journal of the Endocrine Society May 2024Cardiovascular disease (CVD) is the leading cause of death in people with diabetes. Compared with European Americans, African Americans have more favorable lipid... (Review)
Review
Cardiovascular disease (CVD) is the leading cause of death in people with diabetes. Compared with European Americans, African Americans have more favorable lipid profiles, as indicated by higher high-density lipoprotein cholesterol, lower triglycerides, and less dense low-density lipoprotein particles. The less atherogenic lipid profile translates to lower incidence and prevalence of CVD in African Americans with diabetes, despite higher rates of hypertension and obesity. However, African Americans with CVD experience worse clinical outcomes, including higher mortality, compared with European Americans. This mini-review summarizes the epidemiology, pathophysiology, mechanisms, and management of CVD in people with diabetes, focusing on possible factors underlying the "African American CVD paradox" (lower CVD incidence/prevalence but worse outcomes). Although the reasons for the disparities in CVD outcomes remain to be fully elucidated, we present a critical appraisal of the roles of suboptimal control of risk factors, inequities in care delivery, several biological factors, and psychosocial stress. We identify gaps in current knowledge and propose areas for future investigation.
PubMed: 38911352
DOI: 10.1210/jendso/bvae116 -
Transplantation Direct Jul 2024The prevalence of obesity is rising in the general population. Donor obesity (body mass index ≥30 kg/m) may potentially reduce the donor pool and impact outcomes in...
BACKGROUND
The prevalence of obesity is rising in the general population. Donor obesity (body mass index ≥30 kg/m) may potentially reduce the donor pool and impact outcomes in living donor liver transplantation (LDLT).
METHODS
We utilized the national transplant database to investigate the impact of donor obesity on donor and recipient outcomes. This was a retrospective cohort study of all LDLTs performed in the United States between January 2010 and June 2023. Outcomes of interest were analyzed by univariable and multivariable logistic regression. Patient and graft survival was evaluated using Kaplan-Meier and Cox proportional analysis.
RESULTS
Six hundred seventy-four donors with obesity and 3498 donors without obesity were analyzed. Donors with obesity had higher rates of readmission within 1 y of donation (15.9% versus 11.6%; = 0.003). The risk of readmission was significantly different between 6 wk and 6 mo of donation (8.8% versus 5.9%; = 0.036). Donor body mass index (odds ratio [OR], 1.460; 95% confidence interval [CI], 1.129-1.999; = 0.004) and preoperative alkaline phosphatase levels (OR, 1.005; 95% CI, 1.000-1.011; = 0.038) were independent predictors of donor readmission. High LDLT center volume was associated with reduced odds of donor readmission (OR, 0.509; 95% CI, 0.373-0.694; < 0.001). Graft and recipient survival was comparable.
CONCLUSIONS
Selection of living donors with obesity may be a potential avenue to increase the available donor pool without compromising recipient outcomes; however, they are at an increased risk for readmission between 6 wk and 6 mo of donation. The reason for readmission requires further study.
PubMed: 38911275
DOI: 10.1097/TXD.0000000000001673 -
Transplantation Direct Jul 2024Limited information is available regarding outcomes of islet cell isolation (ICI) and transplantation (ITx) using medical assistance in dying (MAiD) donors. We aimed to...
BACKGROUND
Limited information is available regarding outcomes of islet cell isolation (ICI) and transplantation (ITx) using medical assistance in dying (MAiD) donors. We aimed to assess the feasibility and outcomes of ICI and ITx in MAiD donors.
METHODS
ICI and ITx from MAiD were compared with donation after circulatory death (DCD) type III between 2016 and 2023. Differences of isolated islet equivalents (IEQs), numeric viability and other quantitative in vitro metabolic measures were assessed.
RESULTS
Overall, 81 ICIs were available of whom 34 (42%) and 47 (58%) from MAiD and DCD-III, respectively. There were no differences of pancreas and digested tissue weight and islets viability among the 2 groups; however, cold ischemic time was longer in MAiD (11.5 versus 9.1 h; = 0.021). The IEQ ( < 0.001) and percent trapped ( < 0.001) were higher in the DCD-III; however, MAiD islets demonstrated a higher purity ( = 0.020). Overall, 15 ITx were performed of whom 3 (8.8%) and 12 (25.5%) from MAiD and DCD-III, respectively ( = 0.056). Patients had a median fasting C-peptide of 0.51 ng/mL (interquartile range, 0.30-0.76 nmol/L), with no differences between groups (MAiD = 0.52 versus DCD-III = 0.51; = 0.718). The median HbA1c was 6.2% (interquartile range, 5.7%-7%) (MAiD = 6.3% versus DCD-III = 6.1%; = 0.815) and BETA2 scores (MAiD = 7.4 versus DCD-III = 12.8; = 0.229) did not differ.
CONCLUSIONS
ICI from MAiD donor pancreas may be successfully transplanted with comparable outcomes to DCD-III and may be used for research. These results justify additional efforts to consider MAiD as another valuable source of grafts for ITx. Further multicenter studies and larger clinical experience are needed to validate our findings.
PubMed: 38911274
DOI: 10.1097/TXD.0000000000001667 -
Indian Journal of Endocrinology and... 2024
PubMed: 38911120
DOI: 10.4103/IJEM.IJEM_144_24 -
Indian Journal of Endocrinology and... 2024Obesity has erupted as an epidemic around the world. It has set itself as a fast wave among other prevailing specific clusters of non-communicable diseases. The current... (Review)
Review
Obesity has erupted as an epidemic around the world. It has set itself as a fast wave among other prevailing specific clusters of non-communicable diseases. The current study reviews and presents an updated meaningful review of the vast research work performed at schools located in different cities of India. A systematic search was conducted in PubMed, Scopus, Google Scholar and PEDro. Studies representing data on obesity and overweight among children in Indian cities were included in the review. A total of 21 articles with 71,466 participants were included in the review for analysis. Obesity developed in childhood and adolescence is greatly associated with heart disease, stroke and cancer (breast and ovarian in women and prostate in men) in the late stage of life. In India, despite being a country with a faster rate of population becoming overweight and obese in urban areas, in contrast, rural areas are still struggling with malnutrition.
PubMed: 38911116
DOI: 10.4103/ijem.ijem_365_23 -
Indian Journal of Endocrinology and... 2024Gestational diabetes mellitus (GDM) is defined as diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes before gestation....
INTRODUCTION
Gestational diabetes mellitus (GDM) is defined as diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes before gestation. Unrecognized and untreated GDM confers significantly greater maternal and fetal risk, which is largely related to the degree of hyperglycemia. The specific risks of diabetes in pregnancy include but are not limited to, spontaneous abortion, pre-eclampsia, fetal anomalies, macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and respiratory distress syndrome. Additionally, GDM is also implicated in long-term metabolic derangements in the offspring in the form of obesity/overweight, hypertension, dysglycemia, insulin resistance, and dyslipidemias later in life. To determine the prevalence of anthropometric and metabolic derangements in children between 1 and 5 years of age, born to women with GDM.
METHODS
This hospital-based cross-sectional study was conducted between November 2019 and November 2021 at our Pediatric Endocrine Clinic. Women were diagnosed as having GDM based on the American Diabetes Association Criteria (2019). History regarding the treatment of the GDM (diet only/diet and medical treatment) and detailed physical examination, including anthropometry and blood pressure, were recorded. Blood samples were collected from children for the estimation of their metabolic profile.
RESULTS
Overweight, obesity, and severe obesity were present in 18 (11.3%), 2 (1.3%), and 2 (1.3%) children, respectively. Hypertension was found in 21 (19.4%) children. Elevated LDL, triglyceride, and total cholesterol were seen in 3 (1.9%), 84 (52.5%), and 1 (0.6%) children, respectively. Impaired fasting glucose (IFG) was found in 6 (3.8%) children, while 27 (16.9%) subjects were found to be having impaired glucose tolerance after OGTT. Insulin resistance was found in 30 (18.8%) children. GDM mothers with a higher BMI tended to have children with a higher BMI (correlation coefficient, r = .414, < .001). Higher serum triglyceride levels (r = -0.034, = 0.672) were recorded in children, irrespective of the BMI of their mothers. There was no significant correlation of maternal BMI with blood pressure (r = -0.134, = 0.091) or with HOMA-IR (r = 0.00, = 0.996) in children. However, mothers with a higher BMI had children with statistically higher fasting blood glucose (r = +0.339, = <0.001) as well as blood glucose 2 hours after OGTT (r = +0.297, = <0.001). This positive correlation of maternal BMI with the glucose metabolism of their offspring was observed for both male and female genders.
CONCLUSION
Children of women with GDM had a higher BMI, and the mode of treatment for GDM did not lead to differences in childhood BMI. The higher BMI of a GDM mother is associated with altered glucose metabolism in their offspring. Deranged levels of triglyceride across the gender were not found to be statistically significant. This has implications for future metabolic and cardiovascular risks in targeting this group for intervention studies to prevent obesity and disorders of glucose metabolism as one potential strategy to prevent adverse metabolic health outcomes.
PubMed: 38911115
DOI: 10.4103/ijem.ijem_211_23