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Research of Exenatide for Overweight/Obese PCOS Patients With IGR
Plain-language guide to NCT03352869: phase 4 randomized trial of Exenatide, pcos, 183 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03352869
- Phase
- phase 4
- Status
- completed
- Start
- 2017-11-28
- Completion (planned or actual)
- 2018-07-01
- Participants
- 183 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Polycystic Ovary Syndrome; Overweight and Obesity; Disorder of Glucose Regulation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Exenatide for pcos.
It had three arms (groups): Exenatide (experimental), Metformin (active comparator) and Combination (experimental).
The registry classes the interventions as drug.
More on the Plan
The investigators plan to enroll 183 patients.
Then the investigators plan to randomly divide the 183 patients into 3 groups: exenatide group, metformin group, and combination group, with 61 samples for each group.
Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations.
All patients discontinue after 12 weeks of treatment and only routine lifestyle intervention is performed after that.
Who Took Part
Enrollment: 183 actual participants took part.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have PCOS which is diagnosed according to 2003 Rotterdam criteria;. Overweight / obesity diagnostic criteria is based on WHO-WPR ;. IGR diagnostic criteria is based on 1999 WHO diagnostic criteria;. Have no use of other hypoglycemic drugs before 3 months of treatment.
The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: high blood pressure (\>160/100mmhg); active infection; secondary diabetes.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The pcos participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
The Exenatide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Exenatide study: the pcos participants and staff both knew the treatment.
It started in 2017-11-28 with completion listed for 2018-07-01.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide in 183 people with pcos.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, PCOS research.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
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.