Ghrelin Suppression by Octreotide in Prader-Willi

Prader Willis Syndrome Clinical Trial

Official title:

Ghrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01613495
• Other study ID #: eIRB #1265
• Secondary ID: OCTRI # __910___
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2005
• Est. completion date: November 2024

Study information

• Verified date: December 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about how octreotide (Sandostatin LAR® Depot) affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.

Description:

After baseline tests, a nurse will administer monthly injections of Sandostatin LAR® or placebo for 6 months. At the end of this initial 6-month treatment period and a 4-month washout period, study subjects will then crossover to receive the alternative therapy (placebo or octreotide) for an additional 6 months. Subjects will be followed for 16 months total at scheduled visits: 0, 2, 6, 10, 12, and 16 months (Table 2).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: November 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Sandostatin® (octreotide)

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

Related Conditions & MeSH terms

• Prader Willis Syndrome
• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• Placebo
After the first study visit, subjects will begin monthly treatment with either the study drug or a placebo (an inactive substance), which will be continued for the first six months of the study. For the last six months of the study, subjects will be switched to the opposite treatment. During these study periods participants will return monthly for administration of study medication, physical examination, and blood draw to check liver enzymes.
• Octreotide
They will be admitted to the inpatient unit of the OCTRI for testing six times. During each of these visits, testing will include measuring how well glucose (sugar) is processed, how much energy is burned off as heat, their amount of body fat, levels of the hormone ghrelin, and how much food is eaten at a meal. After the first study visit, subjects will begin monthly treatment with either the study drug or a placebo (an inactive substance), which will be continued for the first six months of the study. For the last six months of the study, subjects will be switched to the opposite treatment. During these study periods participants will return monthly for administration of study medication, physical examination, and blood draw to check liver enzymes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ghrelin levels		Change from baseline to 6 months
Primary	Appetite		Change from baseline to 6 months
Primary	Body weight		Change from baseline to 6 months
Secondary	Hormone levels		Change from baseline to 6 months
Secondary	Body composition		Change from baseline to 6 months
Secondary	Energy expenditure		Change from baseline to 6 months
Secondary	Glucose metabolism		Change from baseline to 6 months