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Ghrelin Suppression by Octreotide in Prader-Willi

Primary Purpose

Prader Willis Syndrome

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Octreotide
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    April 13, 2011
    Last Updated
    December 14, 2022
    Sponsor
    Oregon Health and Science University
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    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
    Change from baseline to 6 months
    Title
    Appetite
    Time Frame
    Change from baseline to 6 months
    Title
    Body weight
    Time Frame
    Change from baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Hormone levels
    Time Frame
    Change from baseline to 6 months
    Title
    Body composition
    Time Frame
    Change from baseline to 6 months
    Title
    Energy expenditure
    Time Frame
    Change from baseline to 6 months
    Title
    Glucose metabolism
    Time Frame
    Change from baseline to 6 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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 Sandostatin® (octreotide) subjects who have received other investigational drugs administered or received within 30 days of study entry
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Q Purnell, M.D.
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jonathan Q Purnell, M.D.
    Organizational Affiliation
    Oregon Health & Sciences University Portland, OR
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Ghrelin Suppression by Octreotide in Prader-Willi

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