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Sponsors and Collaborators: |
Duke University National Institutes of Health (NIH) National Center for Research Resources (NCRR) Novartis |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00399893 |
The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS).
Condition | Intervention |
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Prader-Willi Syndrome |
Drug: Octreotide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Investigation of the Developmental, Nutritional and Hormonal Regulation of Ghrelin in Children and Young Adults With Prader-Willi Syndrome (PWS): Octreotide Intervention Sub-Study |
Estimated Enrollment: | 26 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Obesity continues to be a prevalent health concern affecting every race of the American population. According to data from the World Health Organization, 54% of U.S. adults are overweight (body mass index (BMI) >25 kg/m2 ) and 22% are obese (BMI >30 kg/m2) (1). In addition, 25% of U.S. children are overweight or obese (1). Studies show that obese children are likely to become obese adults (2-5). Also, recent studies report significant years of life lost due to the impact of being an obese adult (6, 7). Thus, insights into the pathogenesis of childhood obesity and preventative measures are needed to combat the inevitable increase in worldwide incidence of obesity and its associated co-morbidities. Recent studies have identified a new gastroenteric hormone, ghrelin, as a long-term regulator of energy balance in humans (12). Ghrelin is a 28 amino acid acylated peptide which is an endogenous ligand of the growth hormone secretagogue receptor (GHS-R), a hypothalamic G-protein-coupled receptor (13). Enteroendocrine cells (X/A-like cells) of the stomach are the major site of ghrelin synthesis, although a minor proportion of ghrelin synthesis occurs in other sites such as the hypothalamus, pituitary, duodenum, jejunum and lung (14) (15, 16). The hypothesis that hyperghrelinemia causes some of the features of PWS predicts that this disorder will be ameliorated (partially or completely) by lowering ghrelin levels. We have recently shown that the somatostatin agonist, octreotide, suppresses ghrelin levels in humans. If octreotide remains effective in longer term studies, the drug may become an adjuvant therapy, in addition to growth hormone, to control the insatiable appetite and morbid obesity seen in this condition.
Ages Eligible for Study: | 5 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Andrea M Haqq, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Andrea M. Haqq MD MHS ) |
Study ID Numbers: | 1 K23 RR021979, eIRB#00005426 |
Study First Received: | November 14, 2006 |
Last Updated: | February 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00399893 History of Changes |
Health Authority: | United States: Institutional Review Board |
Childhood obesity Prader-Willi Syndrome Octreotide Ghrelin |
Weight loss Body composition Energy expenditure |
Obesity Antineoplastic Agents, Hormonal Chromosome Disorders Octreotide Body Weight Mental Retardation Genetic Diseases, Inborn Weight Loss |
Abnormalities, Multiple Neurologic Manifestations Nutrition Disorders Overnutrition Prader-Willi Syndrome Congenital Abnormalities Neurobehavioral Manifestations |
Obesity Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Gastrointestinal Agents Chromosome Disorders Octreotide Pharmacologic Actions Mental Retardation Pathologic Processes |
Genetic Diseases, Inborn Therapeutic Uses Syndrome Abnormalities, Multiple Neurologic Manifestations Nutrition Disorders Overnutrition Prader-Willi Syndrome Congenital Abnormalities Neurobehavioral Manifestations |