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Adiposity clinical trials

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NCT ID: NCT05574777 Recruiting - Obesity Clinical Trials

Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity

Start date: April 13, 2023
Phase: N/A
Study type: Interventional

This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity Class III participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary endpoint device or procedure related occurrence of complications according to Clavien-Dindo classification will be determined. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 6 months to assess the outcome of the GMA procedure.

NCT ID: NCT05486338 Recruiting - Obesity Clinical Trials

Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

COMET
Start date: September 2023
Phase: N/A
Study type: Interventional

This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 12 months to assess the outcome of the GMA procedure.

NCT ID: NCT05433688 Recruiting - Adiposity Clinical Trials

Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

BARGASTRO
Start date: October 12, 2022
Phase:
Study type: Observational

The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA). The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

NCT ID: NCT05324488 Recruiting - Type 2 Diabetes Clinical Trials

Diabetes Registry Graz for Biomarker Research

GIRO
Start date: October 21, 2015
Phase:
Study type: Observational [Patient Registry]

The Diabetes registry for biomarker research Graz is a prospective cohort-study including subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity and dyslipidemia, aiming to collect data, blood and urine samples of all subjects on an annual basis.

NCT ID: NCT04838249 Recruiting - Eating Behavior Clinical Trials

Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System

HHS
Start date: May 5, 2021
Phase:
Study type: Observational

Current study aims to characterize five highly interconnected physiological systems in patients undergoing cross-sex hormone therapy - namely glucose and lipid metabolism, energy balance, eating behavior, functional brain networks involved in the regulation of eating behavior and the cardiovascular system - to gain novel insights into the effects of sex hormones on the human body. Gathered information will help to identify pathophysiological mechanisms for the development of overeating/obesity, insulin resistance, and cardiovascular disease. Secondarily, the relationships between the gut and oral microbiomes and metabolomes and circulating bacterial signatures will be investigated in relation to the other pervasive physiological systems. Current study is an observational study. The decision if the patient's request for cross-sex hormone therapy can complied with (i.e., if cross-sex hormone therapy is medically indicated) is made prior to the first contact with the study center and with the outpatients clinic for Endocrinology at the University Hospital in Leipzig. Decision ifor treatment is made according to national and international guidelines. Treatment of study participants with testosterone and estradiol/antiandrogens is not affected by the study. During the course of the study no invasive interventions are being performed.

NCT ID: NCT04777305 Recruiting - Obesity Clinical Trials

The POWER BARIATRIC Trial: Physical Outcomes With Exercise Regimens on BARIATRIC Patients

POWER
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

This study aims to determine how different types of exercise regimens (resistance, aerobic, or combined exercise regimens) can be used to minimize muscle loss and mobilize body fat in severely obese patients after bariatric surgery (BS), despite the rapid surgery-induced weight loss. Additionally, the study will examine how changes in the intestinal microbiota following BS act as a mediation factor that alter tissue-specific responses in muscle and adipose tissue. The study will also evaluate the effect of different types of exercise regimens on cardiometabolic markers, endocrine response, and physical function following BS. Sixty sedentary (regular exercise <1 hour per week) candidates to bariatric surgery at Herzliya Medical Center will be recruited to participate in this six-month-long randomized control study. Participants will be randomly assigned to either one of three exercise regimens intervention groups (aerobic, resistance, or a combined exercise regimen combining aerobic and resistance exercises) or a control group that will receive standard care. Training will be supervised and matched for metabolic equivalent (METs). The intervention will take place at the Sylvan Adams Sports Institute at Tel Aviv University and an online platform. All measurements will be taken at a presurgical baseline assessment and throughout the study, and will include changes of muscle mass and adipose tissue distribution, measured by a 3-Tesla magnetic resonance imaging (MRI); body composition- will be assessed using multichannel bioelectrical impedance (Seca); Bone mass, will be measured by a Dual-energy X-ray absorptiometry (DEXA); microbiota composition and changes will be evaluated by stool samples that will be subjected to 16S ribosomal ribonucleic acid (16s rRNA) profiling and metagenomics analysis; fasting blood samples will be used to examine endocrine control and cardiometabolic markers; anthropometric measurements to assess surgery results associations with physical activity outcomes and physical function will be assessed by several validated performance assessments, including handgrip, six-minute walk, sit-to-stand, maximum voluntary contraction, and maximal oxygen consumption (VO2max).

NCT ID: NCT04098679 Recruiting - Neurologic Disorder Clinical Trials

Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)

Start date: September 30, 2019
Phase:
Study type: Observational

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy). The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

NCT ID: NCT03592732 Recruiting - Atrial Fibrillation Clinical Trials

The Role of Adipokines In Atrial Fibrillation

Start date: March 29, 2018
Phase:
Study type: Observational

The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF.

NCT ID: NCT02427152 Recruiting - Adiposity Clinical Trials

Pre-meal Planning and Expected Satiety

Start date: March 2015
Phase: N/A
Study type: Observational

Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. Further, also factors like weight concern and palatability of the food might have their influence on meal size selection. In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.

NCT ID: NCT02041039 Recruiting - Adiposity Clinical Trials

REWARD SYSTEM RESPONSES TO FOOD AROMAS

Start date: October 2010
Phase:
Study type: Observational

Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption also stimulates appetite, and contributes to overeating while under alcohol's acute effects. Knowing the brain regions that respond to food aromas and alcohol, and how they are modified by the amount of body fat and alcohol exposure, will provide critical information about the neural systems that underlie loss of control of eating. Therefore, the main hypotheses of this study are that: A) Lean and obese subjects have different brain responses to food aromas that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's response to food odors, and ii) affects brain systems that inhibit or terminate eating. To test these hypotheses, we have modified functional magnetic resonance imaging (fMRI) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.