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Peripheral Metabolic Effects of Somatostatin
Plain-language guide to NCT01062529: not phased randomized trial of Somatostatin, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01062529
- Phase
- not phased
- Status
- completed
- Start
- 2009-10
- Completion (planned or actual)
- 2010-02
- Participants
- 8 (actual)
- Design
- randomized, single-blind, basic_science
- Conditions studied
- Acromegaly; Growth Hormone Deficiency; Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Somatostatin.
The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men.
Eight subjects will be enrolled.
The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.
It had 1 arm (groups): somatostatin (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 8 actual participants took part.
It was open to men only aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI \< 27 kg/m2. Written informed consent.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: any disease; any use of medications; present or previous malignancy.
How the Study Was Run
It was run as a randomized, single-group and single-blind study.
The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.
In this single-blind Somatostatin study one party knew the assignments and the other did not.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant.
It started in 2009-10 with completion listed for 2010-02.
It ran at 1 site in Denmark.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Plasma levels of glucose (time frame: 3 months).
It also tracked 2 secondary outcomes, for example GH signalling and Serum levels of free fatty acids (FFA).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Somatostatin in 8 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Somatostatin compound page, all human trials.
Our Notes on the Compound
Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.