Ghrelin Suppression by Octreotide in Prader-Willi

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Placebo

Octreotide

About this trial

This is an interventional treatment trial for Prader Willis Syndrome focused on measuring obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Octreotide

Arm Description

Normal Saline

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.

Outcomes

Primary Outcome Measures

Ghrelin levels

Appetite

Body weight

Secondary Outcome Measures

Hormone levels

Body composition

Energy expenditure

Glucose metabolism

Full Information

NCT ID

NCT01613495

First Posted

April 13, 2011

Last Updated

December 14, 2022

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01613495

Brief Title

Ghrelin Suppression by Octreotide in Prader-Willi

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2005 (undefined)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prader Willis Syndrome

Keywords

obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal Saline

Arm Title

Octreotide

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Octreotide

Other Intervention Name(s)

Sandostatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ghrelin levels

Time Frame