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Ghrelin Suppression by Octreotide in Prader-Willi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01613495
Recruitment Status : Active, not recruiting
First Posted : June 7, 2012
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE April 13, 2011
First Posted Date  ICMJE June 7, 2012
Last Update Posted Date December 16, 2022
Study Start Date  ICMJE August 2005
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • Ghrelin levels [ Time Frame: Change from baseline to 6 months ]
  • Appetite [ Time Frame: Change from baseline to 6 months ]
  • Body weight [ Time Frame: Change from baseline to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • Hormone levels [ Time Frame: Change from baseline to 6 months ]
  • Body composition [ Time Frame: Change from baseline to 6 months ]
  • Energy expenditure [ Time Frame: Change from baseline to 6 months ]
  • Glucose metabolism [ Time Frame: Change from baseline to 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ghrelin Suppression by Octreotide in Prader-Willi
Official Title  ICMJE Ghrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi Syndrome
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prader Willis Syndrome
Intervention  ICMJE
  • 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.
    Other Name: Normal Saline
  • Drug: 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.
    Other Name: Sandostatin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Normal Saline
    Intervention: Drug: Placebo
  • Active Comparator: 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.
    Intervention: Drug: Octreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 4, 2012)		 2
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613495
Other Study ID Numbers  ICMJE eIRB #1265
OCTRI # __910_____ ( Other Identifier: Oregon Health and Sciences University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonathan Purnell, Oregon Health and Science University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Oregon Health and Science University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Q Purnell, M.D. Oregon Health and Science University
Principal Investigator: Jonathan Q Purnell, M.D. Oregon Health & Sciences University Portland, OR
PRS Account Oregon Health and Science University
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP