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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03325569 |
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Date of registration:
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24/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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GLP-1 Response in Women With PCOS and Prediabetes
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Scientific title:
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Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI |
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Date of first enrolment:
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February 13, 2017 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03325569 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Andrej Janez, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years old to menopause
- polycystic ovary sindrome (NICHD criteria)
- BMI of 30 kg/m2 or higher
Exclusion Criteria:
- type 1 or type 2 diabetes mellitus
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of MEN 2
- the use of medications known or suspected to affect reproductive or metabolic
functions
- the use of statins within 90 days prior to study entery
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Incretin Hormones in PCOS With Prediabetes
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Intervention(s)
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Diagnostic Test: oral glucose tolerance test
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Primary Outcome(s)
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The main outcome was difference in fasting and after load GLP1 levels between two groups
[Time Frame: 3h]
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Secondary Outcome(s)
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The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.
[Time Frame: 3h]
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Secondary ID(s)
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IGH PCOS and inkretins
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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