Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00699530
First received: May 23, 2008
Last updated: November 6, 2012
Last verified: November 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 23, 2008 | ||||||||
| Last Updated Date | November 6, 2012 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Insulin sensitivity [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00699530 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment | ||||||||
| Official Title ICMJE | Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment | ||||||||
| Brief Summary | The purpose of this study is to investigate the effects of chronic elevated levels of Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Whole blood, serum, muscle samples, fat samples |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients recently diagnosed with hyperprolactinemia |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Cabergoline
Cabergoline 0,25 - 1,0 mg once a week, controlled by our outpatient clinic. The drug regimen is not influenced by participating in this study.
Other Name: Cabergoline |
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| Study Group/Cohort (s) | Hyperprolactinemia
Patients recently diagnosed with hyperprolactinemia
Intervention: Other: Cabergoline |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | January 2016 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00699530 | ||||||||
| Other Study ID Numbers ICMJE | MM-ISP-20070132 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Aarhus | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE | Aarhus University Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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