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Obesity clinical trials

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NCT ID: NCT04597281 Recruiting - Obesity, Childhood Clinical Trials

MEditerranean LIfestyle in Pediatric Obesity Prevention

MELI-POP
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The current project is a randomized controlled multi-centre clinical trial, in a cohort of children aged 3 to 6 years at baseline and being at obesity risk. The main objective consists on assessing the efficacy of an intervention during early childhood, considering a healthy lifestyle based on the promotion of a Mediterranean dietary pattern and regular physical activity, compared with a control group, on decreasing obesity incidence 5 and 10 years after the beginning of the intervention. It is envisaged to include 738 children, aged 3 to 6 years, having at baseline a body mass index (BMI) < than the equivalent to 30 kg/m2 in adults, and at least one parent having a BMI > 25 kg/m2. The clinical trial will have two arms and will be performed in Primary Health centres in 3 cities: Córdoba, Santiago de Compostela and Zaragoza. The control group will receive usual care by healthcare professionals. The intervention group, will receive education on Mediterranean lifestyle (Mediterranean diet and physical activity promotion), combined with the provision of extra-virgin olive oil and fish, in order to be consumed at least 3 times per week. Physical activity sessions with a physical activity monitor will also be offered for free to the children (2 sessions of 60 minutes of moderate-vigorous physical activity, per week). The participants' degree of compliance with the intervention will be periodically monitored. The main outcome is the incidence of obesity and the secondary outcomes are changes in body composition, physical fitness and cardiovascular risk factors. We are targeting for a 10 year follow-up.

NCT ID: NCT04595006 Recruiting - Obesity Clinical Trials

Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Our body fat (adipose tissue) is largely made up of white adipose tissue (WAT) that stores surplus energy as white fat depots. In addition, adult humans have another type of fat similar to the brown fat in babies that burns up fat to generate heat for maintenance of body temperature during cold exposure. Adults have much lesser amounts of such brown adipose tissue (BAT), most of which are located within the sides of the neck and under the skin above the collar bones as well as along the sides of the spine. BAT consists of both classical brown fat identical to that found in babies as well as beige fat (composed of brown-in-white or 'brite' fat cells) found mainly in adults. Both types of BAT burn fat upon activation by various stimuli such as cold or by substances like curcumin found in turmeric ginger rhizome root. This study is carried out to find out the effects of cold stimulation and/or a known BAT-activating nutraceutical among those overweight/obese people suffering from metabolic syndrome.

NCT ID: NCT04593082 Recruiting - Multiple Sclerosis Clinical Trials

Obesity and Pediatric Multiple Sclerosis

Start date: June 3, 2021
Phase:
Study type: Observational

Obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. We already know that obesity is a risk determinant for acquiring MS, yet the impact of obesity on pediatric MS disease expression and course is unknown. This study will evaluate the relationship between obesity, obesity-derived inflammatory mediators, and imaging metrics of MS severity in children. Understanding how childhood obesity contributes to MS severity/progression may yield fundamental insights into disease pathobiology - which may thereby lead to effective strategies for halting its progression in its earliest stages.

NCT ID: NCT04583150 Recruiting - Obesity Clinical Trials

Ovarian Reserve and Bariatric Surgery

BARIAOVO
Start date: December 3, 2020
Phase:
Study type: Observational

The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. Severe obesity has negative effects on fertility and on in vitro fertilization (IVF) outcomes, and the weight loss induced by the bariatric surgery (BS) is believed to reverse the deleterious impact of overweight and obesity on female fertility. However, research is limited to retrospective cohort studies, small case-series and case-control studies. Weight reduction has been shown to improve fecundity and hormonal state of a subgroup of obese patients with polycystic ovary syndrome (PCOS). In this population, recent studies have demonstrated an increase of naturally conceived pregnancies following bariatric surgery. However, these studies have evaluated only short-term evolution of ovarian function and not all studies demonstrated improvements in fertility outcomes after BS. Clearly, more studies are needed regarding the effect of BS on obesity-related infertility, and long-term outcome of ovarian function has to be assessed. Markers of ovarian reserve, including Follicle Stimulating Hormone (FSH), antral follicle count (AFC), and anti-mullerian hormone (AMH), have been used to counsel patients regarding in their reproductive outcomes. Serum AMH concentrations remain remarkably stable throughout the menstrual cycle, which is a great advantage over other markers of fertility. Various studies have evaluated the association between AMH and body mass index (BMI) but reported contradictory results. Some of them have reported a significant inverse correlation between AMH and BMI, but others found no relationship between AMH and BMI. Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH.

NCT ID: NCT04581980 Recruiting - Obesity Clinical Trials

Effects of Obesity and Intensity of Exercise on Ghrelin Levels

Start date: October 14, 2020
Phase: N/A
Study type: Interventional

This study is investigating the effect of different intensities of exercise on levels of the hormone, ghrelin. In addition, we will be examining the relationship between any exercise induced changes in ghrelin and insulin sensitivity, obesity, and vascular function.

NCT ID: NCT04578652 Recruiting - Insulin Resistance Clinical Trials

Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance [IR]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM. .

NCT ID: NCT04575506 Recruiting - Obesity Clinical Trials

Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver

MicroKid
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)

NCT ID: NCT04575194 Recruiting - Obesity Clinical Trials

Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

Start date: September 8, 2020
Phase: Phase 4
Study type: Interventional

The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.

NCT ID: NCT04573998 Recruiting - Obesity; Endocrine Clinical Trials

Study on the Mechanism of lcn2 in Obesity

Start date: July 1, 2016
Phase:
Study type: Observational

Obesity is now becoming a worldwide serious problem. Obesity is associated with a spectrum of severe diseases, including diabetes, cardiovascular diseases, and cancers. Lipocalin 2 (LCN2), also known as neutrophil gelatinase associated lipocalin (NGAL), is a member of the lipocalin family. Due to its upregulated expression in infection, LCN2 is originally considered to be a key regulator of immune response. Subsequent investigations revealed that LCN2 is expressed in many tissues and is related to a variety of diseases, including obesity. LCN2 was reported to be increased in obesity individuals. Thus, the investigators decide to investigate the relationship between LCN2 and obesity.

NCT ID: NCT04570527 Recruiting - Obesity Clinical Trials

Optimized Cardioprotection Therapy in Obese Subjects With CAD

Start date: January 1, 2019
Phase:
Study type: Observational

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With coronary artery disease (CAD).