Obese

Birthweight below the 10th (small for gestational age or SGA) or above the 90th (large for gestational age or LGA) percentile for gestational age has been associated with adverse maternal, fetal and neonatal outcomes. As birthweight reflects intrauterine development, accurate identification of abnormal fetal growth would allow obstetric providers to prevent adverse outcomes and mitigate complications associated with abnormal development. Symphysis fundal height (SFH) measured in centimeters after 24 weeks of gestation is recommended as the standard of care to screen for fetal growth abnormalities among low-risk pregnancies. This method is low-cost, and easy to perform, but there is a lack of evidence supporting its effectiveness due to its poor sensitivity. Ultrasonography, the technique utilized to identify fetal growth abnormalities, is a costly procedure which involves the use of advanced equipment and providers, to perform and review the ultrasound, as well as a full examination with multiple measurements and images. Despite a few encouraging reports, insufficient evidence supports routine 3rd trimester ultrasound in low- risk pregnancies to improve detection of abnormal fetal growth. Sonographic measurement of the abdominal circumference (AC) in the fetus was shown to be the single most useful indicator of fetal growth. Measurement of AC does not require extensive training, long time to acquire, or expensive ultrasound machines. It can be easily performed in the office by midwives who are specifically trained in obtaining the measurement. Therefore, we intended to evaluate if the use of bedside point of care ultrasound (POC-US) by midwives to evaluate fetal AC during routine antenatal visits in low-risk pregnancies would increase the accuracy of SFH in identifying fetuses with birthweight \< 10th or \> 90th, when compared to SFH alone. This is an open label, investigator sponsored, two arms randomized controlled trial. Patients who satisfy all inclusion criteria, have no exclusion criteria, and have signed the written informed consent will be randomly assigned to screening of fetal growth abnormalities during routine antenatal appointments held by midwives according to SFH or SFH + POC-US-AC. Low risk pregnant women are interviewed by a midwife at 35-38 weeks' gestation, who also reviews their medical and obstetrical history, prenatal labs and the ultrasound reports to discriminate between high and low-risk pregnancies. Patients who satisfy all inclusion criteria and do not have any exclusion criteria will be randomly assigned to one of two different approaches to identify fetal growth abnormalities and predict abnormal birthweight, after signing the written informed consent. Screening test in the control group: Symphysis fundal height measurement. Fundal height is measured by trained midwives at each scheduled antenatal appointment from the pubis symphysis to the top of the uterine fundus, using a paper measuring tape in centimeters. Size greater than dates is suspected if the measurement is above the 90th gestational age specific percentile according to the Intergrowth 21 SFH references (Papageorghiu 2016). Similarly, size less than dates is recorded if the measurement is below the 10th percentile for age according to the Intergrowth 21 SFH references (Papageorghiu 2016). Formal obstetric ultrasound is requested if the SFH is \> 90th percentile, if it is \< 10th , or if it drops 50 growth centiles in two subsequent evaluations. Screening test in the intervention group: Symphysis fundal height measurement + point of care ultrasound. After assessing SFH at each clinical encounter, the midwife will perform a POC-US to measure the fetal AC and evaluate the quantity of amniotic fluid. A positive screen for fetal growth restriction (indicative of a potential SGA infant) consists in a measured AC less than the 10th percentile for gestational age according to the standards defined by Nicolini et al in 1986 on an Italian population; instead, a positive screen for macrosomia (suggestive of a potential LGA infant) is an AC greater than the 90th percentile for gestational age according to the references set by Nicolini et al in 1996. Formal obstetric ultrasound is requested if the AC is \> 90th percentile, if it is \< 10th, or if it drops 50 growth centiles in two subsequent evaluations. Amniotic fluid volume will be evaluated determining the deepest vertical pocket (DVP). A formal US is requested in case uterine size is measured as ≤ than the 10th or ≥ than the 90th percentile for gestational age according to Intergrowth 21, when POC - US reveals AC \< 10th percentile, AC \> 90th percentile according to Nicolini et al, in case DVP \< 2 x 1 cm, or DVP \> 8 x 1 cm, or also if SFH or AC drop \> 50 percentiles comparing two subsequent evaluations. Patients randomized to SFH + POC-US will have a formal US if either technique suspects abnormal fetal growth. Formal US requested due to an abnormal screening test will be distinguished from scans ordered due to other indications, such as hypertensive disorders of pregnancy, or cholestasis of pregnancy diagnosed after enrollment. Hadlock' s references will be used to estimate fetal weight, and therefore to define FGR (i.e estimated fetal weight or AC \< 10th percentile) as well as macrosomia (i.e estimated fetal weight or AC \> 90th percentile). Prenatal evaluation of fetal growth will be compared to the birthweight percentile according to the INeS neonatal charts (Bertino 2010) to identify SGA, LGA and AGA (appropriate for gestational age) infants. After the initial evaluation low risk pregnancies are scheduled for antenatal appointments with a midwife at 40, 41 and 41+ weeks' gestation. All patients will have a POC-US by a midwife at 41, and 41+ weeks' gestation to screen for amniotic fluid abnormalities associated with protracted pregnancy, independently of the randomization arm. A midwife will perform SFH or SFH + POCT-US (according to randomization) at enrolment (35-38 weeks' gestation) and at 40 weeks. As sonographic assessment of fetal growth should not be performed more frequently than every 2 weeks due to the error associated with measurements; POC-US will only evaluate amniotic fluid volume at 41 and 41+3 weeks' gestation (unless the patient has missed a previous appointment), even among women randomized to SFH + POC-US. The purpose of the study is to evaluate the most accurate approach to identify prenatally those pregnancies that will result in SGA or LGA infants. Prenatal evaluation consists in a universal screening test for fetal growth abnormalities (either SFH or SFH + POC US) followed by a confirmatory test (formal obstetric US) performed only when the initial screening test is positive. Fetal growth or amniotic fluid abnormalities are diagnosed in utero if confirmed by a formal obstetric ultrasound, and not when only suspected by a screening test; in fact, the study seeks to evaluate what is the most accurate combination of screening and confirmatory tests, and not the effectiveness of the screening test alone.

In Years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. The lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. Attendance at each lesson will be limited to 30 individuals. Attendees will register via REDCap using their names and email addresses. There is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. At each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. Surveys will take \~5-10 minutes to complete. Additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in Projects Years 1 - 5. Total sample for this activity is 700. Each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Background Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way. Objectives The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice. Design A prospective, observational cohort study Study center General Hospital (AZ) Sint-Jan Brugge-Oostende Population The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015. Endpoints The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI). Duration In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data. Conclusions Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.

Background: One-in-four Canadians will develop atrial fibrillation (AF), increasing risk of heart failure and stroke. Obesity (i.e., BMI ≥30 kg/m2) represents a strong, independent risk factor for increased incidence and severity of AF. Weight loss reduces AF symptom burden, and patients with obesity who lose ≥10% of their body weight may achieve AF regression/remission. Cardiac rehabilitation (CR) improves AF risk factors including hypertension and cardiorespiratory fitness (CRF), yet the efficacy of CR for reducing AF symptom burden is not established. CR rarely includes targeted obesity management and, on average, has a negligible impact on BMI. Adding behavioural weight-loss treatment (BWLT) to traditional CR may therefore enhance weight loss and lead to improvements in AF prognosis, symptoms, and health-related quality-of-life (HRQOL) in patients with AF and obesity. Given the high prevalence of obesity among individuals with AF, and its detrimental effect on AF burden and outcomes, there is a critical need for interventions that can support weight-loss-promoting behaviours and can be integrated into routine clinical care for AF. CR programs are available in all major Canadian cities and have a proven track-record of achieving clinically-relevant improvements in important AF risk factors including hypertension, lipid profile, and exercise capacity. Therefore, CR represents an ideal setting to promote risk factor management for patients with AF. Yet, because traditional CR does not produce meaningful weight loss there is a clear gap in the ability of current CR programming to meet the needs of a growing population of individuals with AF and obesity. The addition of a novel BWLT component to CR is needed to bridge this gap and provide the appropriate treatment regimen of comprehensive risk factor management, exercise, and weight loss to achieve optimal AF outcomes. The primary aim is to: Assess whether the combination of an AF-specific 'small changes' BWLT and traditional CR results in a greater proportion of patients with AF and obesity achieving ≥ 10% body weight loss compared to patients who receive standard care (traditional CR alone). The secondary aims of the proposed study are to evaluate the impact of BWLT+CR on: 1) mean % weight loss of controls vs. intervention group; 2) AF burden; 3) self-reported AF symptom burden; 4) disease-specific and generic patient-reported outcome measures (e.g., AF- and health-related quality-of-life \[HRQoL\]; psychological distress); and 5) exercise volume measured in weekly steps. Hypotheses: The primary study hypothesis is that patients in the BWLT+CR group will be more likely to achieve ≥10% weight loss at 12 months post-randomization relative to the CR-only group. Secondary hypotheses are that: patients in the BWLT+CR group will experience greater improvements in AF burden, AF self-reported symptom burden, increased HRQoL, decreased psychological distress, and increased leisure-time exercise and CR exercise session attendance relative to the CR-only group. Study design: Design and Procedure. Patients will be assessed for eligibility at TotalCardiology Rehabilitation (TCR). Eligible patients who consent to participate will be enrolled into the CR program and randomized to either the BWLT+CR or CR-only group. Prior to randomization, patients will complete a questionnaire battery including socio-demographic variables (age, sex, ethnicity, income, education), self-reported weight and height to establish BMI, and validated questionnaires assessing AF symptom burden, AF-related quality-of-life, general HRQOL, and psychological distress at baseline (T1). Patients will be re-administered the test battery following the 12-week BWLT+CR program, or 12 weeks of the CR-only program (T2). (Note: T2 measures will be administered even if the patient is still completing their remaining CR exercise sessions. CR completion/adherence will be determined after patients have completed their 12-week exercise program). The test battery will be administered for a final time approximately 24 weeks post-randomization. Weight loss from baseline to 52-weeks will be calculated and converted to a percentage of initial body weight at baseline. Clinical variables (e.g., CRF from graded exercise tests; blood pressure, lipids) will be obtained by TCR chart review. Recruitment. Patients will be recruited in two ways: (1) directly from TotalCardiology Rehabilitation using referrals from Dr. Wilton and TCR clinic staff, and (2) from an existing database of patients who participated in the Part I qualitative study and Part II acceptability study that provided consent to be contacted about future studies. The recruitment period will be from October 2022 to April 2024. Equal numbers of men and women will be recruited. AF clinic patients who are both (a) eligible for the CR program and (b) eligible for the proposed study will be identified by Dr. Wilton and/or TCR clinic staff. Dr. Wilton/TCR clinic staff will inform patients who meet (a) and (b) criteria about the study and invite them to participate. Interested patients will receive a CR referral and their contact information will be provided to the research coordinator. The research coordinator (B. Valdarchi) will contact patients, provide additional information about the study, and obtain informed consent. The research coordinator will then send an email link to complete baseline questionnaires. Following the completion of the questionnaires, participants will be informed about the group they were randomized to, and scheduled for BWLT groups if needed. Concurrently, patients will be contacted by CR staff to schedule their orientation appointment, as per typical clinic procedures. This recruitment procedure will also apply to patients who previously participated in Part I and II (i.e the qualitative and acceptability studies, respectively). TCR patients who are currently enrolled in CR will also be recruited. A research team member will identify CR patients who have consented to be approached about research and who are eligible for inclusion by reviewing patient chart data. An RA will contact patients by telephone to review study procedures and obtain patients' informed consent. Sample Size/Analysis. Analysis will be by intention to treat. Conservatively assuming a 5% success rate in the control group and a 30% success rate in the intervention group, 78 patients (39 per group) will provide 80% power to detect a difference using a two-sided independent test of proportions with a 5% significance level. The investigators estimate loss to follow-up and drop-outs of 20% and 10% respectively, therefore 120 patients will be recruited in total (60 per group). The primary analysis will compare the proportion in each group achieving ≥10% weight loss between baseline and 52 weeks post-randomization. A secondary per-protocol analysis will be performed including only participants who complete at least the initial 12-weeks of the BWLT. AF burden will be calculated as a % of total ECG tracings and compared between treatment and controls. Self-reported secondary outcomes will be evaluated using linear mixed modelling.

Acute lymphoblastic leukemia (ALL) has been referred to as a "pre-obese state", with many studies describing the onset of obesity during treatment. Weight gain typically begins within the first month of ALL diagnosis, stabilizes, and then resumes at the beginning of maintenance and continues into survivorship. Children and adolescents with healthy weight at diagnosis are the most vulnerable to weight gain; up to 70% develop overweight/obesity (OW/OB) by the end of treatment (EOT). Weight gain during treatment is one of the most consistently reported risk factors for weight gain in survivorship and is associated with an increased odds of being OW/OB 5-years post-EOT. Significant clinical ramifications are associated with being OW/OB. A meta-analysis led by the Children's Oncology Group nutrition committee found that OW/OB is associated with a 31% increased risk of mortality in ALL. The objective of the study team is to prevent the development of OW/OB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL. Once enrolled, subjects will be randomized to PEDALL or standard of care (SOC). Subjects in the PEDALL group will receive 26 contact hours of specialized nutrition education and counseling via a virtual platform. The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OW/OB compared to SOC during maintenance chemotherapy. The clinical impact of this study will improve the understanding of pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight gain among patients treated for ALL. Study findings may lead to the allocation of limited clinical resources to individuals most susceptible to OW/OB. Information obtained from this study may also direct the refinement of counseling techniques to enhance the likelihood of success over the course of treatment for ALL and into survivorship. The long-term goal is to enhance the likelihood of success of weight maintenance during therapy thereby mitigating excess toxicities during treatment and reducing nutrition-related late-effects associated with OW/OB among survivors of childhood ALL.

Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism "diabesity". This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.

Impaired blood flow through microvessels (arterioles and capillaries) leads to irreversible damage to cells within the affected watershed. In addition to hypertension and age, Type-2 diabetes (DMII) independently contributes to microvascular disease. Distinct from other diabetic complications, the impact of diabetes on neurovascular function has not clearly been shown to correlate with measures of hyperglycemia or peripheral glucose regulation. The pathophysiology underlying the association between type-2 diabetes, vascular injury and neural damage, including CNS parenchymal loss and PNS neuropathy, remains uncertain. Normally amylin, a byproduct of the synthesis of insulin by pancreatic β-cells, crosses the blood brain barrier and binds to neurons in feeding centers where it is believed to induce anorexic effects. Amylin aggregates are found in microvessels of pancreas, brain, hearts and kidneys of individuals with DMII or obesity. The investigators have demonstrated amylin aggregates in microvessels of peripheral nerves in rats overexpressing human amylin (unpublished). It is unknown whether amylin deposits are a consequence or a trigger of vascular injury, but they are clearly associated and may present a potential target for reducing diabetes-associated microvascular disease. Furthermore, their accumulation in peripheral nerve microvasculature and red blood cells (RBCs) offers possible foci for a peripheral biomarker of diabetes-induced CNS microvascular disease. Hypothesis: Patients with DMII have significant amylin deposition in the peripheral vasa nervorum and on RBCs that correlates with severity of clinical peripheral polyneuropathy and reduction of peripheral nerve conduction velocities (NCVs); these amylin measures thereby become surrogates of microvascular disease and may serve as metrics of disease severity. Aim: Obtain serum HbA1c, skin punch biopsy, RBCs, NCVs and clinical sensory examination from forty consenting adults previously diagnosed with DMII. Skin biopsy from volar forearm and red blood cell samples will be processed for amylin deposition. This pilot study will provide preliminary data to fuel a larger, potentially multi-center, clinical trial investigating the utility of peripheral amylin or RBC amylin as a quantitative biomarker of microvascular disease that would include monitoring the effect of potential therapies. Measuring serum HbA1c will allow for possible correlation to chronic extracellular glucose concentration. Based on our preliminary data from a rat model of type-2 diabetes that expresses human amylin in the pancreas, the investigators anticipate an increased amylin deposition in the skin blood vessels with the progression of type-2 diabetes as measured by sensory examination and NCVs. Although not directly measured in this study, our preliminary data from the analysis of amylin deposition in cerebral blood vessels of patients with type-2 diabetes suggest that APOE 4 carriers, at risk for developing dementia, may have an increased propensity to accumulate amylin deposits in blood vessels. Thus, the ability to easily identify and target a potential driver of microvascular disease may help prevent the devastating effects of the vascular complications of DMII, including cardiovascular disease, retinopathy, nephropathy and dementia.

PERIODS is a prospective, phase IV, multi-centre, randomized, double-blind and placebo-controlled clinical trial that will investigate the effects of tirzepatide compared with placebo on ovarian dysfunction in premeno-pausal, overweight (BMI ≥ 27 kg/m2) women with PCOS. The primary endpoint is the improvement of ovarian dysfunction as defined by menstrual irregularity and ovulation frequency in overweight or obesity-related PCOS. All subjects will undergo a screening visit and a 72-week treatment period including a 20-week dose escalation up to the maximum tolerated dose. Lower doses of tirzepatide are permitted if intolerable side effects occur. However, even if a lower dose of tirzepatide turns out to be the maximum tolerated dose, this lower dose will be administered for the entire 20-week dose escalation period, followed by the 52-week maintenance dose. The safety follow-up period will be 4 weeks (for subjects completing or discontinuing IMP during the first 72 weeks). Long-term follow-up will be one year after discontinuation of IMP. The trial design is multi-centred with a planned number of 5 participating trial sites in Germany.