Overview

Ghrelin Suppression by Octreotide in Prader-Willi

Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to learn more about how octreotide (Sandostatin LARĀ® Depot) affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Oregon Health and Science University
Treatments:
Octreotide
Criteria
Inclusion Criteria:

- o Diagnosis of PWS confirmed by chromosome analysis (i.e. interstitial deletion of
paternally-derived chromosome 15Q, uniparental maternal disomy or other chromosome 15
abnormalities)

- Age 18 years and older

- Written informed consent obtained (by subject or guardian) and willingness to
comply with the study schedule and procedures

- Free T4, TSH values in the normal range (with or without thyroxine replacement)

- Subjects with confirmed hypogonadism who are corrected with adequate doses of sex
steroid replacement, will have been treated for at least 6 months prior to entry
and have no change in dosages over the study period.

- Patients with confirmed growth hormone deficiency who are corrected with adequate
doses of replacement, will have been treated for at least 6 months prior to entry
and have no change in dosages over the study period.

Exclusion Criteria:

- Symptomatic gallstones.

- Smokers.

- Alcohol consumption > 2 drinks per day.

- Exercise > 30 minutes 3 times a week.

- Weight > 500 lbs (exceeds the limit for the BODPOD).

- Active pulmonary infection.

- Sleep disorder.

- Subjects will be excluded if they have clinically significant disease that would have
an impact on metabolic outcomes or body composition including diabetes mellitus,
chronic inflammatory bowel disease, chronic severe liver or kidney disease, heart
disease, cancer, symptomatic gallstones, or neurological disorders

- history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of
normal for LFTs indicative of hepatic steatosis, MAY participate)

- pregnant or lactating

- known hypersensitivity to Sandostatin acetate or other related drug or compound

- subjects who exhibit symptoms indicative of intolerance following the 100 mcg test
dose of Sandostatin Injection, SC

- subjects who have previously received SandostatinĀ® (octreotide)

- subjects who have received other investigational drugs administered or received within
30 days of study entry