Ghrelin Suppression by Octreotide in Prader-Willi

What Was Tested

The trial (not phased) is built around Octreotide.

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.

It had two arms (groups): Placebo (placebo comparator) and Octreotide (active comparator).

Normal Saline.

The registry classes the interventions as drug.

More on the Plan

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).

Who Took Part

Enrollment: 2 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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).

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: symptomatic gallstones; alcohol consumption \> 2 drinks per day; exercise \> 30 minutes 3 times a week.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2005-08 with completion listed for 2024-03.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 4 secondary outcomes, for example Hormone levels, Body composition, Energy expenditure and Glucose metabolism.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 2 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.