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Found 11 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying adolescents with Anorexia Nervosa AN and normal weight to understand body composition, basal metabolic rate BMR, and physical activity levels. AN has the highest mortality rate among eating disorders, with significant relapse rates and varied recovery outcomes. Monitoring changes in weight, body composition, and metabolic rates is crucial to better define the clinical stages of AN. The study uses bioelectrical impedance analysis BIA to measure parameters like lean mass, fat mass, total body water, and phase angle, which relate to body composition and BMR. Physical activity is also assessed as it influences body composition and metabolism. Participants include female adolescents with AN and female adolescents with normal weight. Participants will have measurements taken for fat-free mass, fat mass, and basal metabolic rate at the start of the study. Researchers will collect anthropometric and biochemical data, along with questionnaires about physical activity. This observational study helps identify key factors in the clinical assessment of AN over its course. The study runs from July 2024 to July 2026.

Age: 12Years - 18YearsFEMALE
1 location
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Actively Recruiting

Healthy Volunteer

Obesity is a growing health concern affecting many older adults, often accompanied by sarcopenia, which is the gradual loss of muscle mass and strength. This combination leads to a condition called sarcopenic obesity, which reduces strength and the ability to perform daily activities. Researchers aim to understand how excess body fat impacts physical abilities and daily living in obese older adults by comparing them with normal-weight peers matched by age and sex. The study observes two groups of adults aged 65 and older those who are obese with a body mass index over 35 and those with normal weight having a body mass index between 20 and 25. Participants undergo anthropometric measurements, physical fitness tests, and complete questionnaires about their daily activities. The obese group is hospitalized for a 3-week metabolic rehabilitation program, while the normal-weight group participates in a healthy lifestyle program in their hometown. Participants will be assessed using measures such as fat mass, lean mass, the Barthel Index to evaluate daily living activities, and handgrip strength test at the start of the study. This observational approach helps researchers examine the differences in body composition and physical function between the two groups. The study is expected to continue until the end of 2026, providing valuable insights into the effects of obesity on elderly adults physical abilities and daily life.

Age: 65Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating the effects of 10 sessions of whole-body cryostimulation WBC on patients with obesity, fibromyalgia, osteoarthritis, and neurological conditions such as Parkinsons disease, Multiple Sclerosis, and Disimmune Polyneuropathies. The study aims to understand whether WBC can improve thermogenesis, reduce chronic inflammation, pain, fatigue, and enhance physical and psychological functions across these groups. It also investigates the impact on blood catecholamine levels and sympathetic nervous system responses affecting body composition, blood pressure, heart rate, lipid profile, and physical performance. Participants will be non-randomly assigned to either a multidisciplinary rehabilitation program involving diet and exercise alone or the same program combined with 10 WBC sessions over two weeks. WBC sessions involve exposure to extremely cold, dry air at -110C for 2-3 minutes in a cryochamber, with close monitoring of skin temperature and blood pressure before and after each session. The rehabilitation program includes a balanced hypocaloric Mediterranean diet and supervised physiotherapy with aerobic and strengthening exercises performed daily. During the study, participants will undergo evaluations including body composition analysis, blood tests for catecholamines and inflammatory markers, and physical performance tests such as the six-minute walk test, Timed Up and Go test, and hand grip strength. Various questionnaires will assess general health, pain, fatigue, sleep quality, psychological well-being, and disease-specific conditions. Data will be collected at admission and after two weeks of treatment, with follow-up questionnaires extending up to 12 months to monitor changes in health status and symptoms.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

This research aims to evaluate how effective a multidisciplinary rehabilitation program is for people with severe obesity, comparing those who receive a special formula of essential amino acids combined with tricarboxylic acids EAA-AC to those who do not. The study focuses on patients aged 45 to 65 with high-grade obesity. Researchers want to see if the amino acid supplement improves weight loss, muscle mass, mitochondrial function, and metabolic health. Participants will be randomly assigned to one of two groups. One group will follow a low-calorie, low-protein diet supplemented with four sachets per day of the EAA-AC formula for two weeks. The other group will follow the same diet but receive a placebo instead of the supplement. After the treatment period, patients will have a one-month outpatient follow-up to check muscle mass maintenance using body impedance analysis. During the study, researchers will assess muscle mass at the start and after two weeks, along with body composition and physical function tests like hand grip strength and walking tests 6MWT or TUG. They will also analyze mitochondrial function and circulating mitochondrial DNA levels. Blood tests will evaluate glucose control and lipid profiles. After discharge, participants return for a follow-up visit to evaluate muscle mass maintenance. The total participation period includes the initial two weeks of treatment plus the one-month follow-up.

Age: 45Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the presence of metacognitive beliefs in adolescent girls with eating and nutrition disorders END compared to a control group of similar age and sex from the general population. The study aims to understand how these beliefs, along with brooding and rumination, relate to END, using diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders DSM-5. The study includes two groups female adolescents aged 12 to 17 years with a diagnosis of END, and a control group of female adolescents without such a diagnosis, all of Italian nationality. Participants are observed for factors involved in eating and nutrition disorders, focusing on symptom patterns and cognitive processes such as metacognitive beliefs, brooding, and rumination. Participants will undergo assessments of their metacognitive beliefs, brooding, and rumination at baseline. The study observes these psychological factors without administering treatments. Researchers will monitor these measures to understand their relationship to eating and nutrition disorders. The total participation duration and follow-up details are not specified.

Age: 12Years - 17YearsFEMALE
1 location
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Actively Recruiting

Researchers are studying metacognitive beliefs, emotional regulation, and emotional eating in adults with obesity to understand how these factors may relate to each other. This observational study focuses on patients aged 18 to 65 who have a body mass index BMI of 35 or higher, based on World Health Organization criteria, and are of Italian nationality. Participants will complete several questionnaires including the Metacognition Questionnaire, Penn State Worry Questionnaire, Ruminative Response Scale, Anger Rumination Scale, Difficulties in Emotion Regulation Scale, and the Emotional Eating subscale of the Dutch Eating Behavior Questionnaire. These tools help assess different aspects of thinking patterns, emotional regulation, and eating behaviors. During the study, researchers will evaluate baseline measures of metacognitive beliefs, rumination, anger rumination, emotional dysregulation, and emotional eating. The study does not involve treatment but collects data through questionnaires to explore these psychological factors in obese patients. Participation involves completing these assessments and providing informed consent.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying the methylation of the Orexin A OX-A and Orexin B OX-B gene promoters in young women aged 18 years and older with Anorexia Nervosa AN. The study compares these methylation levels with those in a control group of women with normal weight. It also evaluates how gene methylation relates to the severity of eating disorder symptoms, depression, and sleep quality. Participants include two groups young women hospitalized with Anorexia Nervosa and a control group of women of similar age with a Body Mass Index BMI between 18.5 and 24.9 kgm2. The study collects blood samples to analyze gene promoter methylation and uses questionnaires to assess eating disorder severity, depression, daytime sleepiness, sleep quality, and circadian preferences. Participants will provide blood samples and complete several questionnaires including the Eating Disorder Examination Q, Eating Disorder Inventory 3, Major Depression Inventory, Symptom Checklist-revised, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Horne & Ostberg questionnaire. The primary outcomes measured at baseline are the methylation levels of the Orexin A and B gene promoters. The study is observational and sponsored by Istituto Auxologico Italiano.

Age: 18Years +FEMALE
1 location
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Actively Recruiting

REM Sleep Behavior Disorder RBD is a condition where the normal muscle paralysis during REM sleep is lost, causing abnormal and sometimes violent movements often linked to dreams. This disorder can exist on its own, called idiopathic RBD iRBD, or be associated with neurological diseases like Parkinsons Disease and Lewy Body Dementia. Researchers are studying RBD to understand its progression and to identify markers that predict when iRBD patients may develop related neurodegenerative diseases, as well as to characterize different patient subtypes and quality of life impacts. The study is observational and collects clinical, biological, neurophysiological, neuropsychological, and imaging data from participants diagnosed with iRBD. These data are gathered using standardized and harmonized procedures to identify predictive risk factors and distinct phenotypes of iRBD. The goal is to create a well-characterized group of patients ready for future trials of disease-modifying therapies, including monoclonal antibodies targeting alpha-synucleinopathies. Participants will be followed over many years, with assessments including video-polysomnographic recordings vPSG, clinical exams, questionnaires, and imaging tests. Researchers will track the development of alpha-synucleinopathies, quality of life changes, and correlations between muscle activity loss during REM sleep and cognitive performance. The primary outcome is identifying risk factors for disease progression, with monitoring continuing through January 2035 to capture long-term data on conversion rates and patient well-being.

Age: 18Years +All Genders
2 locations
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Actively Recruiting

Researchers are evaluating the sphingolipidomic profile in adult women diagnosed with Anorexia Nervosa AN, including its two main types restricting AN-R and binge-eating purging AN-BP. This observational study aims to understand how these lipid profiles relate to the severity of the eating disorder, depressive symptoms including suicidality, and gonadal function by measuring hormone levels and contraceptive use. The goal is to use these insights to improve dietary rehabilitation programs and treatment effectiveness over time. The study involves two groups women with Anorexia Nervosa who are hospitalized at a specialized nutrition disorders division, and a control group of healthy women with normal body weight. Researchers will analyze plasma and serum levels of various sphingolipids, such as ceramides, dihydroceramides, sphingomyelins, sphingosine, and related metabolites. These measurements will help define the specific lipidomic profiles associated with the disorder. Participants will complete questionnaires assessing eating disorder severity and depressive state, along with clinical evaluations of hormone levels to understand endocrine status. The primary outcomes focus on baseline levels of ceramides and dihydroceramides. The study is observational, so participants will be monitored without intervention, and the research team will use collected data to explore clinical, endocrine, and psychiatric relationships. Participation involves blood sample collection and questionnaire completion, with the study expected to continue until mid-2026.

Age: 18Years +FEMALE
1 location
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Actively Recruiting

This observational study focuses on male patients aged 18 to 80 years with severe obesity. It aims to evaluate the secretion levels of cortisol and testosterone and the sensitivity of their receptors. Researchers want to understand if these hormonal factors are linked to changes in bone metabolism, lipoprotein concentration and function, and the severity or complications of obesity. The study also investigates whether these hormone patterns can predict cardiovascular disease in obese patients. Participants will undergo assessments including questionnaires about mood and symptoms, collection of medical history and clinical data related to obesity complications, and measurements of body mass index BMI. Blood samples will be collected and analyzed at a central laboratory to study steroid hormones, bone metabolism, lipoprotein function, genetics, and receptor sensitivity. Cortisol suppression will be tested using a 1 mg dexamethasone test. During the study, data collected at enrollment and laboratory analyses will help measure the association of androgen and cortisol hormone levels with obesity severity and cardiovascular risk. The research team will also examine the prevalence of hypogonadism and resistance to cortisol suppression in the participants. The study is led by Istituto Auxologico Italiano and runs through June 2026.

Age: 18Years - 80YearsMALE
1 location

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