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Weight Gain clinical trials

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NCT ID: NCT00709202 Completed - Schizophrenia Clinical Trials

Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation. B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation. C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation

NCT ID: NCT00708461 Completed - Obesity Clinical Trials

Environmental Intervention for Weight Gain Prevention

HealthWorks
Start date: January 2006
Phase: N/A
Study type: Interventional

The primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.

NCT ID: NCT00698022 Completed - Healthy Clinical Trials

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Start date: November 2008
Phase: Phase 1
Study type: Interventional

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

NCT ID: NCT00690235 Completed - Schizophrenia Clinical Trials

Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

Start date: November 2007
Phase: Phase 4
Study type: Interventional

Primary Objective: To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.

NCT ID: NCT00687115 Completed - Obesity Clinical Trials

Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting

Start date: September 18, 2008
Phase: Phase 2
Study type: Interventional

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: - Medical history, physical examination and laboratory studies - Questionnaires to assess eating behavior, food preferences, body composition, and activity level - Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) - Oral glucose tolerance test - Meal test to measure the response of certain hormones to food - Activity monitors to determine activity level - Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature - Free-living energy use study to measure calories burned under normal home conditions over 7 days - Fat and muscle biopsies - Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: - Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) - Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test

NCT ID: NCT00686426 Completed - Obesity Clinical Trials

Role of Dairy Products in Weight Maintenance

Start date: November 2003
Phase: N/A
Study type: Interventional

The goal of the current study is to determine the role of dairy in similarly preventing weight and fat re-gain in obese adults who have successfully completed a weight loss diet program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet for two years. Macronutrient distribution will be maintained constant and set at approximately the U.S. average. Primary outcomes include changes in body weight, body fat and anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure, circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight regain in humans has not yet been assessed in clinical trials.

NCT ID: NCT00683891 Completed - Weight Gain Clinical Trials

FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey

FOCUS
Start date: n/a
Phase: N/A
Study type: Observational

AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo showing that FazaClo patients start losing body weight instead of keep gaining it, after being switched from other clozapine products or other atypical antipsychotics treatments. Another important clinical observation reported by doctors is a considerable reduction in hypersalivation when FazaClo administration is compared to other antipsychotic treatments. Based on the findings described above, and on the real need for effective and safer treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational study in a large number of patients taking FazaClo to prove the received clinical reports from physicians. Better understanding and evaluation of these beneficial findings are necessary to provide physicians information for improved treatment decision.

NCT ID: NCT00680979 Completed - Obesity Clinical Trials

Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity

Start date: May 15, 2008
Phase: Phase 2
Study type: Interventional

This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain. Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures: Visit 1 - Height and weight measurements. - Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors. Visit 2 - Physical examination, blood and urine tests. - DXA scan to measure body fat, muscle and bone mineral content. - Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms. - Interview about the child s mood and psychological functioning. Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.

NCT ID: NCT00637572 Completed - HIV Infections Clinical Trials

Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

NCT ID: NCT00636896 Completed - Weight Gain Clinical Trials

Effects of Modafinil on Olanzapine Weight Gain

Start date: July 2006
Phase: N/A
Study type: Interventional

This study is designed as a 3 week, randomized, double blind, placebo controlled, trial. Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety, kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be drawn at baseline and endpoint prior to breakfast and two hours post. Study hypothesis: The modafinil/olanzapine group will gain less weight than the olanzapine/placebo group over three weeks of drug intake.