Search Bar & Filters
Found 10 Actively Recruiting clinical trials
Actively Recruiting
This research focuses on adolescents with Anorexia Nervosa (AN), a serious eating disorder with a high mortality rate and frequent relapses. The study aims to identify key body composition and metabolic parameters to better define the clinical stage of AN. It compares these factors in adolescents with AN and those with normal weight, highlighting the importance of monitoring changes in weight, body composition, and metabolic rate to support disease management. The study involves collecting various measurements using bioelectrical impedance analysis (BIA) to assess body composition including lean mass, fat mass, total body water, and phase angle. Basal metabolic rate (BMR) and physical activity levels are also monitored as they relate to body composition and disease progression. Participants undergo collection of anthropometric and biochemical parameters, as well as completion of questionnaires to gather comprehensive data. Participants are female adolescents aged 12 to 18 years, either diagnosed with AN and hospitalized at a specific Italian hospital or of normal weight. Researchers will measure fat-free mass, fat mass, and basal metabolic rate at the start. The study emphasizes continuous monitoring of body composition and metabolic changes alongside physical activity to better understand and track the clinical status of AN over time.
Actively Recruiting
Researchers are investigating the effects of 10 sessions of whole-body cryostimulation (WBC) on patients with obesity, fibromyalgia, osteoarthritis, and neurological conditions such as Parkinson's disease, Multiple Sclerosis, and Disimmune Polyneuropathies. The study aims to evaluate whether WBC can improve thermogenesis, reduce inflammation, pain, fatigue, and enhance physical, psychological, and functional abilities. The trial also measures blood catecholamine levels and assesses the sympathetic nervous system's impact on body composition, blood pressure, heart rate, lipid profile, and physical performance. Participants will undergo either a rehabilitation program alone or combined with 10 WBC sessions over two weeks. The rehabilitation includes a balanced hypocaloric Mediterranean diet, psychological support, and supervised physical activity with aerobic, postural, and strengthening exercises. WBC sessions involve exposure to extremely cold air at -110 B0C for 2-3 minutes in a cryochamber, with careful monitoring of skin temperature and blood pressure before and after treatment. During the study, participants will have their body composition, blood samples, skin temperatures, muscle strength, and functional capacities assessed at the start and after two weeks. Various questionnaires will evaluate general health, pain, fatigue, sleep quality, mood, psychological well-being, and disease-specific impacts. The primary outcome measured is the change in blood catecholamine levels from baseline up to three weeks. Safety and progress will be closely monitored throughout the trial.
Actively Recruiting
Researchers are studying how a low-protein diet supplemented with a new formula of essential amino acids and tricarboxylic acids (EAA-AC) affects people with severe obesity aged between 45 and 65. The study aims to compare the effects of this supplementation combined with a low-calorie, low-protein diet against a similar diet with a placebo, focusing on weight loss, muscle mass maintenance, and metabolic improvements. Participants will be randomly assigned to one of two groups for a two-week period: one group will receive the low-calorie, low-protein diet along with 4 sachets per day of the EAA-AC supplement, while the other group will follow the same diet but with a placebo. After this intervention, patients will be monitored one month after discharge with an outpatient check-up to assess muscle mass maintenance using impedance testing. Throughout the study, researchers will evaluate changes in muscle mass at the start and after two weeks of treatment, using body composition measurements and functional tests such as hand grip strength and walking tests. They will also analyze mitochondrial function and blood markers related to metabolism. The study will track weight loss, glucose control, and lipid profiles to understand the metabolic effects of the dietary interventions.
Actively Recruiting
Researchers are investigating metacognitive beliefs in adolescent females aged 12 to 17 years who have eating and nutrition disorders (END), comparing them to a control group of similar age and sex from the general population. The study focuses on understanding symptom patterns, metacognitive beliefs, brooding, and rumination in these groups to better characterize END in adolescents. Participants will be observed for various factors related to eating and nutrition disorders, including their symptomatology, metacognitive beliefs, brooding, and rumination. The study involves detailed observation without specific treatment interventions, aiming to gather information that differentiates affected adolescents from healthy controls. During the study, participants will undergo assessments measuring metacognitive beliefs, brooding, and rumination at baseline. Researchers will collect data through observations and questionnaires to evaluate these psychological factors. The total participation period and follow-up details are not specified, but all evaluations focus on baseline characteristics relevant to END in adolescent females.
Actively Recruiting
Researchers are studying the presence of metacognitive beliefs, emotional regulation, and emotional eating in patients with obesity. The study aims to explore possible relationships between these psychological factors and obesity in adults aged 18 to 65 years with a body mass index of 35 kg/m2 or higher. Participants will complete several questionnaires designed to assess various psychological aspects including metacognition, worry, rumination, anger rumination, difficulties in emotion regulation, and emotional eating. The questionnaires used include the Metacognition Questionnaire, the Penn State Worry Questionnaire, the Ruminative Response Scale, the Anger Rumination Scale, the Difficulties in Emotion Regulation Scale, and the Emotional Eating subscale of the Dutch Eating Behavior Questionnaire. During the study, participants will be assessed at baseline for metacognitive beliefs, rumination, anger rumination, emotional dysregulation, and emotional eating. These assessments will be conducted through the completion of the questionnaires. The research focuses on understanding these psychological measures in obese patients and does not involve drug treatments or other interventions. The total participation duration is not specified.
Actively Recruiting
Healthy Volunteer
This research aims to understand the methylation levels 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). It compares these levels with those in a control group and explores how gene methylation relates to the severity of the eating disorder, associated psychiatric conditions like depression, and sleep quality. The study focuses on female participants to investigate these connections in the context of AN. Participants will provide blood samples to measure methylation of the OX-A and OX-B gene promoters. Alongside this, they will complete several questionnaires assessing eating disorder symptoms, depression, and sleep quality, including the Eating Disorder Examination Questionnaire, Eating Disorder Inventory 3, Major Depression Inventory, Symptom Checklist-revised, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and the Horne & Ostberg questionnaire. This combination of biological and questionnaire data helps evaluate the study's objectives. Women hospitalized at the Division of Eating and Nutrition Disorders in Italy, along with a control group of healthy women, will take part. Researchers will collect and analyze blood samples and questionnaire responses to measure gene methylation and assess eating disorder severity, depressive symptoms, and sleep patterns. The main outcomes focus on baseline methylation levels of Orexin A and Orexin B promoters. Participation involves a one-time visit for sample collection and questionnaires, with no long-term follow-up described.
Actively Recruiting
REM Sleep Behavior Disorder (RBD) is a sleep disorder characterized by loss of normal muscle paralysis during REM sleep, leading to abnormal and sometimes violent movements related to dreams. This disorder is classified as idiopathic RBD (iRBD) when it occurs without other neurological diseases. Researchers are studying iRBD because it often precedes neurodegenerative diseases like Parkinson's Disease and Lewy Body Dementia. The study aims to identify different patient subgroups and predictive risk factors for conversion from iRBD to these neurodegenerative conditions, using a variety of clinical, biological, neurophysiological, neuropsychological, and imaging biomarkers collected in a standardized way. The study will collect longitudinal data from adults diagnosed with iRBD to find correlations between diverse biomarker data and patient phenotypes. This approach includes advanced neural network analyses to better understand disease progression and develop patient stratification methods. The goal is to create a trial-ready cohort of iRBD patients who can participate in future trials testing disease-modifying therapies, such as monoclonal antibodies targeting alpha-synucleinopathies. The study is endorsed by the Italian Association of Sleep Medicine and the RBD Patients Society. Participants will be monitored over time for the development of neurodegenerative diseases, with the primary outcome being the identification of predictive risk factors for phenoconversion. Data collection will involve clinical exams, questionnaires, biological samples, and various imaging and neurophysiological tests. The study will follow patients from May 25, 2020, to January 31, 2035, to observe long-term outcomes. This comprehensive monitoring aims to improve understanding of iRBD and support future therapeutic interventions at early stages of neurodegeneration.
Actively Recruiting
Researchers are studying the sphingolipidomic profile in women aged 18 years and older who have Anorexia Nervosa (AN). The study focuses on two types of AN: the restricting type (AN-R) and the binge-eating/purging type (AN-BP). Participants will complete questionnaires to assess the severity of their eating disorder and depressive symptoms, including suicidality. The study also evaluates gonadal function by measuring plasma levels of estradiol, progesterone, and the use of oral contraceptives. The intervention involves measuring plasma and serum levels of various sphingolipids, including ceramides and dihydroceramides ranging from C16 to C24, sphingomyelins, sphingosine, sphinganine, and their phosphorylated forms. These detailed measurements aim to characterize the lipidomic profile associated with Anorexia Nervosa. This profile could help tailor dietary rehabilitation programs and improve treatment effectiveness, especially over the long term. Participants will be women hospitalized with Anorexia Nervosa or part of a control group with a normal body mass index. Researchers will collect blood samples to measure sphingolipid levels and administer specific clinical questionnaires. The primary outcomes are the baseline levels of ceramides and dihydroceramides. The study also includes assessments of clinical, endocrine, and psychiatric parameters to understand the relationship between these factors and lipid profiles.
Actively Recruiting
Researchers are studying obese male patients aged 18 to 80 to understand how their hormone levels of cortisol and testosterone, along with hormone receptor sensitivity, may relate to changes in bone health, lipoprotein levels and function, and the severity and complications of obesity. They will also explore whether this hormone environment can predict cardiovascular disease risk in these patients. The study focuses on men with severe obesity who do not have other known causes of hormone imbalances such as hypercortisolism or hypogonadism. This observational study collects questionnaires on mood and symptoms at enrollment, along with medical history, clinical data about disease complications, body mass index, and past blood test results. A dexamethasone suppression test (1 mg) is performed to assess cortisol function. Blood samples are analyzed centrally to study steroid hormones, bone metabolism, lipoprotein function, genetics, and hormone receptor characteristics. Participants are evaluated through clinical and laboratory assessments including hormone levels and receptor studies. Researchers measure associations between hormone profiles and obesity severity, bone health, and cardiovascular risk. The study aims to identify hormonal factors linked with obesity complications and cardiovascular disease. The total participation duration and follow-up details are not specified in the summary.
Actively Recruiting
Researchers are evaluating the effects of whole body vibration exercise (WBVE) on resting energy expenditure and other health parameters in obese adolescent boys. These participants are hospitalized for a 3-week integrated metabolic rehabilitation program that includes calorie restriction, aerobic exercise, psychological counseling, and nutritional education. The study compares outcomes between those receiving standard rehabilitation alone and those who also undergo WBVE training. Participants are divided into two groups: one follows the standard multidisciplinary metabolic rehabilitation protocol, and the other receives the same rehabilitation plus 24 sessions of WBVE spread over 3 weeks (2 sessions per day, each lasting 30 minutes) on a vibration platform. The study takes place during the hospitalization period at a specialized medical center in Italy. During the study, researchers measure resting energy expenditure at the start and after 3 weeks using indirect calorimetry. They also assess cardiovascular and musculoskeletal function through specific tests. The program involves close monitoring and evaluation of participants' progress throughout the rehabilitation period.