Ghrelin Suppression by Octreotide in Prader-Willi

NCT01613495 | Unknown

• 2 other identifiers: eIRB #1265OCTRI # __910_____
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prader Willis Syndrome

Keywords

obesity

Outcome Measures

Primary Outcomes (3)

• Ghrelin levels

  Change from baseline to 6 months

• Appetite

  Change from baseline to 6 months

• Body weight

  Change from baseline to 6 months

Secondary Outcomes (4)

• Hormone levels

  Change from baseline to 6 months

• Body composition

  Change from baseline to 6 months

• Energy expenditure

  Change from baseline to 6 months

• Glucose metabolism

  Change from baseline to 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Octreotide

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

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.

Also known as: Normal Saline

Placebo

Octreotide DRUG

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.

Also known as: Sandostatin

Octreotide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Prader-Willi Syndrome; Obesity

Interventions

Saline Solution; Octreotide

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jonathan Q Purnell, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Jonathan Q Purnell, M.D.

  Oregon Health & Sciences University Portland, OR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: June 7, 2012
• Study Start: August 1, 2005
• Primary Completion: March 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 16, 2022

Record last verified: 2022-12