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Anorexia clinical trials

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NCT ID: NCT01906320 Completed - Clinical trials for Anorexia Nervosa Restricting Type

Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

The aim is to test the hypothesis that high-resistance training for 8 weeks, following the recommendations for healthy adolescents, is capable of eliciting increases in muscle strength, agility, skeletal muscle mass, and functional capacity without losing weight, body mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we hypothesize that the effects produced by the high-resistance training program will be maintained 4 weeks following the completion of the training program.

NCT ID: NCT01849107 Completed - Diarrhea Clinical Trials

Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

Start date: April 2013
Phase: N/A
Study type: Interventional

Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.

NCT ID: NCT01823822 Completed - Anorexia Nervosa Clinical Trials

Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa

Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum Insulin-like Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested product or control product for 4-week, followed by a 4-week follow-up.

NCT ID: NCT01801397 Recruiting - Clinical trials for Low Bone Mass in Anorexia Nervosa Patients

A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa Patients With Low Bone Mineral Density and Increased Bone Fagility (FAN-Trial)

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Study Title: A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia Nervosa patients with low mineral density and increased bone fragility (FAN-Trial) Short Title/Study ID: FAN-Trial / Psy-Rheu_2011/1 Indication: Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available) without fragility fractures in Anorexia Nervosa patients Trial Design: Open-label, single-centre pilot study with study drug treatment duration of 24 months. Study Center: Single-centre (University Hospital of Zürich) Investigator(s)/Authors: PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091 Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg Objective(s)/Outcome(s): Primary endpoint: •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone density at months 12 and 24. Secondary endpoints: - To assess the changes in blood biomarkers - To assess changes in whole body composition - To assess the incidence of new fragility fractures - To assess changes in bone structure - To assess the changes in EDE-Q - Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN Assessments for primary endpoint: •BMD at lumbar spine, total hip and femoral neck, measured by DXA Assessments for secondary endpoints: - bone resorption and bone formation markers measured in urine and serum - whole body composition measured by DXA - New clinical peripheral and vertebral fractures - HRqCT of tibia and forearm - EDE-Q Score at months 12 and 24 Safety measurements: - Safety lab (blood and urine) - Clinical adverse event monitoring at all visits Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: - Women, aged > 18 to < 35 years - Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening - Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score < -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) without any previous fragility fracture - or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) and at least one previous fragility fracture - In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and Psychotherapy of the University Hospital of Zurich. Main Exclusion Criteria: - Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV positive patients, pregnancy, open epiphyses - Incapacity to understand the aims of the study or patients not willing to collaborate. Study Product, Dose, Route, Regimen: Teriparatide (Forsteo®), 20µg s.c. daily for 24 months. Duration of study: 24 months. Reference therapy, Dose, Route, Regimen: - Trial with medicinal product

NCT ID: NCT01772394 Completed - Young Adult Clinical Trials

Cognitive Remediation Therapy in Anorexia Nervosa

TreCogAM
Start date: October 2012
Phase: N/A
Study type: Interventional

"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered. The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."

NCT ID: NCT01761942 Unknown status - Anorexia Nervosa Clinical Trials

Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa

FASAN
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

NCT ID: NCT01740752 Completed - Anorexia Nervosa Clinical Trials

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

UCAN2
Start date: July 2012
Phase: N/A
Study type: Interventional

Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. The study examines two comprehensive treatments as couples face the challenges of anorexia nervosa (AN). The program helps patients with AN and their partners address AN symptoms and unique stresses that AN places on the romantic relationship.

NCT ID: NCT01717079 Terminated - Anorexia Nervosa Clinical Trials

rTMS and Body Shape Perception

STIMOREX
Start date: May 2013
Phase: N/A
Study type: Interventional

Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN. This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS. Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described). Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.

NCT ID: NCT01678014 Recruiting - Anorexia Clinical Trials

Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa

Start date: April 2012
Phase: Phase 1
Study type: Interventional

Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and young adult women. There are many methods in the treatment of AN, such as family therapy, cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory to all current medical treatment and never fully recover and the standardized mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and capsulotomy are the most used methods which has been proved effective in obsessive and compulsive disorders, depression and other psychiatric disorders. Many case reports indicate that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there are some common pathways between AN and other psychiatric disorder. The investigators have a hypothesis that deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.

NCT ID: NCT01642550 Completed - Anorexia Nervosa Clinical Trials

Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.