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Obesity, Morbid clinical trials

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NCT ID: NCT06426290 Recruiting - Body Weight Changes Clinical Trials

Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

PREDI-CHIRBA
Start date: May 30, 2024
Phase:
Study type: Observational

This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project. The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery. The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success.

NCT ID: NCT06410820 Recruiting - Obesity, Morbid Clinical Trials

Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients

Start date: May 16, 2024
Phase: N/A
Study type: Interventional

This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section. The primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.

NCT ID: NCT06341699 Recruiting - Obesity, Morbid Clinical Trials

Study of the Steroid Hormone Milieu in Obese Patients

MiSterO
Start date: May 16, 2023
Phase:
Study type: Observational

The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity. It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients. Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism. Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.

NCT ID: NCT06338969 Recruiting - Obesity, Morbid Clinical Trials

The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Background: Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates. Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH). The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis. Objectives: The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year.

NCT ID: NCT06309563 Recruiting - Weight Loss Clinical Trials

Metabolic Effects of a Diet Replaced With Essential Amino Acids

AMINOB
Start date: August 30, 2023
Phase: N/A
Study type: Interventional

The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile. 1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.

NCT ID: NCT06297928 Recruiting - Clinical trials for Bariatric Surgery Candidate

Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity

Start date: January 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are: - Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery? - How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery? - What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery? Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery.

NCT ID: NCT06293703 Recruiting - Morbid Obesity Clinical Trials

Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)

CLIMB II
Start date: January 12, 2024
Phase: N/A
Study type: Interventional

The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.

NCT ID: NCT06268990 Recruiting - Diabetes Clinical Trials

FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

DACH
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.

NCT ID: NCT06264427 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland. The main questions it aims to answer are: - Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes? - Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment? - What is the prevalence of sleep apnea among high-risk individuals in Greenland? - Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea? Participants will: - Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness - Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy - Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation - Blood samples for full genome sequencing

NCT ID: NCT06234111 Recruiting - Obesity Clinical Trials

Semaglutide and Physical Activity for Obesity and Multimorbidity

Start date: February 20, 2024
Phase:
Study type: Observational

The aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity. This study is explorative and therefore does not include hypothesis testing.