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Ghrelin Suppression by Octreotide in Prader-Willi

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ClinicalTrials.gov Identifier: NCT01613495
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Prader Willis Syndrome Drug: Placebo Drug: Octreotide Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ghrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi Syndrome
Study Start Date : August 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : November 2010


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal Saline
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
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.
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



Primary Outcome Measures :
  1. Ghrelin levels [ Time Frame: Change from baseline to 6 months ]
  2. Appetite [ Time Frame: Change from baseline to 6 months ]
  3. Body weight [ Time Frame: Change from baseline to 6 months ]

Secondary Outcome Measures :
  1. Hormone levels [ Time Frame: Change from baseline to 6 months ]
  2. Body composition [ Time Frame: Change from baseline to 6 months ]
  3. Energy expenditure [ Time Frame: Change from baseline to 6 months ]
  4. Glucose metabolism [ Time Frame: Change from baseline to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613495


Sponsors and Collaborators
Oregon Health and Science University
Investigators
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

Responsible Party: Jonathan Purnell, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01613495     History of Changes
Other Study ID Numbers: eIRB #1265
OCTRI # __910_____ ( Other Identifier: Oregon Health and Sciences University )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Jonathan Purnell, Oregon Health and Science University:
obesity

Additional relevant MeSH terms:
Syndrome
Prader-Willi Syndrome
Hyperphagia
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents