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Obesity clinical trials

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NCT ID: NCT04201938 Completed - Obesity Clinical Trials

Effect of Probiotic Co-administration With Omega-3 Fatty Acids on Obesity Parameters and Insulin Resistance

ENDO-5
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Omega-3 fatty acids belong to the family of polyunsaturated fatty acids. They are known to exert a strong positive influence on metabolism and inflammation. The data from animal studies suggested that both probiotics and omega-3 can affect body weight, influence on glucose and fat metabolism, improve insulin sensitivity and reduce chronic systemic inflammation. In respect to experimental data, the current study aim was to provide double-blind single center RCT, for study the efficacy of co-administration of probiotic with omega-3 vs. placebo in type 2 diabetes patient

NCT ID: NCT04201028 Completed - Obesity Clinical Trials

A Remote Delivered Lifestyle Therapeutics Program

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Approximately 32% of the adult U.S. population has high blood pressure and 46% of them have uncontrolled hypertension. Successful management of high blood pressure and other cardiovascular risk is a complex process that requires significant lifestyle changes but adopting and adhering to these changes is challenging. A promise approach to overcoming these challenges is utilizing health coaching. The purpose of this research study is to compare at home devices for blood pressure and weight measurements (DEV) group compared to not using any at home devices Group (NODEV). Both groups will be supported throughout this study by meeting with obesity medicine doctor monthly in office and have a virtual health coaching visits throughout the study duration.

NCT ID: NCT04199611 Completed - Mental Health Issue Clinical Trials

Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health.

NCT ID: NCT04198220 Completed - Atrial Fibrillation Clinical Trials

BIO|STREAM.ICM Obesity

Start date: September 17, 2020
Phase:
Study type: Observational

The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

NCT ID: NCT04197336 Completed - Obesity Clinical Trials

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

BAE2
Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Obesity is defined as a body mass index (BMI) ≥30 kg/m2 and with a subclass of obesity known as morbid or severe obesity (BMI of ≥40 kg/m2). These are major issues in medicine for both participants and medical providers with >36% of the US population affected. Obesity is one of the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81% higher healthcare costs than non-obese adults. Obesity is currently treated with dietary, pharmacological, and/or surgical approaches that are often unsuccessful or are associated with additional risks. As the incidence and prevalence of obesity and obesity-related diseases are steadily increasing, there is a growing need to detect the key risk factors involved in disease development and modify standard treatment procedures and protocols. The most successful long-term strategy continues to be bariatric and metabolic surgeries, such as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater and obesity related comorbidities. These surgeries enable participants to lose between 50% and 75% of excess body weight. Despite this success, participants are apprehensive and do not undergo bariatric surgery with the biggest fear being the many complications that come with the procedure. Studies have shown that 57-77% of participants are not interested in bariatric surgery although the participants qualify.(16) With the concern of complications from bariatric surgery, interest in endoscopic bariatric techniques has increased over the years. The techniques have been shown to be efficacious, reversible, relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some participants who may otherwise be unable to undergo bariatric surgery. The American Society for Gastrointestinal Endoscopy have approved endoscopic procedures, such as balloon therapy, for participants with BMI in the 30-40 kg/m2 range.(17,18) However, the products used in these therapies also have several limitations primarily the inability to provide long term weight loss given the temporary nature of these balloons.(19) Common adverse events following intragastric balloon insertion include abdominal pain (33.7%), gastroesophageal reflux disease (18.3%), anorexia, and nausea (29%). Severe complications such as gastric ulcers (2%), small bowel obstruction (0.3%), perforation (0.1%), balloon migration (1.4%), and death (0.08%) are less common. Early balloon removal occurred in 9.1% of the study participants due to participant intolerance.(20) In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants with a BMI of ≥40 kg/m2 with no other comorbid conditions underwent bariatric embolization and were followed for 12 months. Participants were embolized with 300-500 µm Embospheres. None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date) had any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and were completely healed by three months after the procedure.(21) There were many limitations of this study including the absence of a control cohort and non-compliance amongst study participants. A target population of participants with a BMI of 40 kg/m2 and above was too high considering the bariatric embolization procedure is comparable to endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity excluded participants with comorbidities, such as those who suffer from diabetes, who may greatly benefit from this procedure and are often the target population for endoscopic/surgical bariatric therapies. A larger bead size of 300-500 µm was specifically chosen compared to preclinical data and prior clinical reports due to concerns of gastric ischemia and ulceration. However, smaller bead size produces greater weight loss and hormonal shifts.(22) Investigators hypothesize that transvascular bariatric embolization results in safe and effective weight loss in obese participants compared to control subjects.

NCT ID: NCT04195061 Completed - Insulin Resistance Clinical Trials

Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Start date: December 12, 2019
Phase:
Study type: Observational

The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.

NCT ID: NCT04193384 Completed - Obesity Clinical Trials

Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.

Obesity
Start date: November 1, 2018
Phase:
Study type: Observational

The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.

NCT ID: NCT04190459 Completed - Obesity Clinical Trials

Quality of Life 10 Years After Bariatric Surgery

Qol-10
Start date: May 1, 2009
Phase:
Study type: Observational

Importance: Improvement of the QoL after bariatric surgery is an important outcome of the treatment. The investigators believe that assessment of distant QoL results, could provide new insight into effectiveness of most popular bariatric procedures. Objective: The investigators aim to analyze the bariatric surgery effect on the long term QoL, considering the type of surgery. Design: A cohort study including patients undergoing bariatric surgery. Setting: One academic referral center. Exposures: Patients undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Roux-en-Y Gastric Bypass . Surgical technique is standardized and consistent in the whole study group. Main Outcomes and Measures: The main outcome is the change of QoL after bariatric surgery. It is assessed in three different time points: pre-surgery, first follow up (1 year after surgery) and second follow-up (10 years after surgery). The investigators use two licensed and standardized questionnaires: (Short Form Health Survey) and MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II).

NCT ID: NCT04189848 Completed - Obesity Clinical Trials

Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

Start date: December 3, 2019
Phase: Phase 4
Study type: Interventional

This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

NCT ID: NCT04189289 Completed - Obesity Clinical Trials

Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

Start date: December 3, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery