Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399893
Status:
TERMINATED
Last Update Posted:
2014-07-24
First Post:
2006-11-14
Brief Title:
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome PWS
Sponsor:
Duke University
Organization:
Duke University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 SyndromePWS
Detailed Description:
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 US adults are overweight body mass index BMI 25 kgm2 and 22 are obese BMI 30 kgm2 1 In addition 25 of US 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 XA-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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 00005426 | OTHER_GRANT | NIH1K23-RR021979 GCRC M01-RR-30 NCRR | None |