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Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Plain-language guide to NCT00042601: phase 2 randomized trial of Amylin (Islet Amyloid Polypeptide), 51 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00042601
- Phase
- phase 2
- Status
- completed
- Start
- 2002-07
- Completion (planned or actual)
- 2003-10
- Participants
- 51 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Amylin (Islet Amyloid Polypeptide).
This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
It had two arms (groups): Placebo (placebo comparator) and Pramlintide (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 51 actual participants took part.
It was open to men only aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Treated with insulin for at least 6 months prior to screening. BMI between 20-40kg/m2.
The full record lists 3 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was randomized, crossover and triple-blind.
The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Amylin (Islet Amyloid Polypeptide) and the comparison in turn, acting as their own control.
Neither the participants nor the staff measuring them knew who was on Amylin (Islet Amyloid Polypeptide), so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2002-07 with completion listed for 2003-10.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in satiety of participants on Pramlintide (time frame: 2 Weeks). Change in food intake of participants on Pramlintide (time frame: 2 Weeks).
It also tracked 1 secondary outcome, for example Effect of pramlintide on postprandial metabolic and hormonal responses.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 51 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.
Our Notes on the Compound
Amylin (Islet Amyloid Polypeptide): A 37-amino-acid hormone released with insulin that slows stomach emptying and signals fullness; pramlintide (Symlin) is a synthetic version.
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.