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Obesity, Metabolically Benign clinical trials

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NCT ID: NCT05232695 Completed - Clinical trials for Metabolically Healthy Obesity

Brown Fat Tissue Related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals

Start date: April 1, 2021
Phase:
Study type: Observational

There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. It was previously thought that only infants have brown adipose tissue, however today it is known that metabolically active brown adipose tissue exists in adult humans as well. Brown adipose tissue contributes to metabolic health through both energy expenditure and the cytokines they secrete. Although obesity is frequently associated with many metabolic dysfunctions and cardiometabolic diseases such as insulin resistance, prediabetes, atherogenic dyslipidemia, metabolic syndrome, some obese individuals have been defined as metabolically healthy obese. The mechanisms underlying the formation of the metabolic healthy obese phenotype are not well understood. In experimental animal studies, it has been suggested that the molecular phenotype of adipose tissue is an important factor affecting metabolic health in obese individuals. One of the most important factors affecting the molecular phenotype of adipose tissue is the browning potential of adipose tissue. Based on this hypothesis, in this study it is aimed to investigate whether the browning of white adipose tissue has an effect on determining the metabolic phenotype of metabolically healthy and unhealthy obese individuals with the same amount of adipose tissue. It is known that irisin, FGF21 and NRG4 are hormones that have the ability to brown the white adipose tissue. In our study, it was aimed to investigate whether there is a difference in serum FGF21, irisin and Neuregulin4 (NRG4) levels, which have brown adipose tissue browning potential, in metabolically healthy and unhealthy obese. In this way, it will be found out whether serum FGF21, irisin and NRG4 hormones, which have a browning effect on white adipose tissue, have an effect on the metabolic health of obese individuals and whether these hormones can be a treatment target. In this project, participants who have BMI ≥30 kg/m2 and no criteria other than metabolic syndrome criteria, except increased waist circumference (blood pressure ≥130/85 mmHg, fasting blood glucose ≥100 mg/dl, triglyceride ≥150 mg/dl, HDL <40mg/dl in men, <50 mg/dl in women) and those without prediabetes will be defined as metabolically healthy obese, on the other hand other obese individuals will be defined as metabolic unhealthy. 10 ml blood samples will be taken from at least 60 metabolically healthy and 60 metabolically unhealthy participants. Serum FGF21, irisin and NRG4 levels will be measured and their levels in metabolically healthy and unhealthy obese individuals will be compared.

NCT ID: NCT04698135 Completed - Morbid Obesity Clinical Trials

Establishment of the Human Intestinal and Salivary Microbiota Biobank - Obesity

BIOMIS-Endo
Start date: March 25, 2021
Phase:
Study type: Observational

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with morbid obesity, metabolically healthy obesity and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological) The study will allow to: - Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients to the first Italian microbiota biobank; - Study microorganisms using different in vitro and in vivo techniques; - Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

NCT ID: NCT04233528 Completed - Obesity Clinical Trials

Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer. However, recently a new classification has emerged about obesity, the metabolically healthy obesity (MHO). According to the definition of the term, MHO represents obesity that occurs segregated from the metabolic syndrome criteria defined by the International Diabetes Federation (IDF). However, as there is still disagreement about the definition of MHO, the cardiovascular risk of these individuals is also uncertain. This phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to MUO, represents a higher risk of developing CVDs. The hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of CVD. In the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

NCT ID: NCT03875898 Completed - Clinical trials for Healthy Obesity, Metabolically

Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact

Breath
Start date: June 8, 2017
Phase: N/A
Study type: Interventional

The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)

NCT ID: NCT03861754 Completed - Obesity Clinical Trials

Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study

LILA
Start date: January 28, 2004
Phase: N/A
Study type: Interventional

Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction. Design 36-month, 4-group parallel, randomized trial. Setting Oulu, Finland. Participants 120 obese adults (body mass index ≥ 30). Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6. Measurements Body weight (primary outcome) and waist circumference (secondary outcome)

NCT ID: NCT03553381 Completed - Metabolic Syndrome Clinical Trials

Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Start date: December 30, 2010
Phase:
Study type: Observational

Obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.

NCT ID: NCT03435978 Completed - Clinical trials for Obesity, Metabolically Benign

Effect of Diet and Physical Activity on Adipokines

Start date: January 1, 2016
Phase: N/A
Study type: Observational

The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).

NCT ID: NCT03354676 Completed - Clinical trials for Obesity, Metabolically Benign

Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?

ChildObes
Start date: March 11, 2016
Phase: N/A
Study type: Observational

Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to investigate the relationship between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese children, and to determine whether these adipokines are significant markers in defining metabolic syndrome in pediatric population

NCT ID: NCT03322514 Completed - Appetite Regulation Clinical Trials

Colonic Propionate, Appetite, and Weight Loss

ProAp
Start date: March 29, 2017
Phase: N/A
Study type: Interventional

The current protocol aims to investigate the impact of the propionate ester in conjugation with restricted diet on appetite and weight loss.

NCT ID: NCT03195712 Completed - Obesity Clinical Trials

Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

Start date: September 4, 2012
Phase: N/A
Study type: Observational

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.