Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
Sponsor
University of Aarhus (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00699530
Collaborator
Aarhus University Hospital (Other)
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Nov 1, 2016
Actual Study Completion Date
:
Nov 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hyperprolactinemia Patients recently diagnosed with hyperprolactinemia |
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.
|
Outcome Measures
Primary Outcome Measures
- Insulin sensitivity [Before and after treatment]
Secondary Outcome Measures
- QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance [Before and after treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Written consent
-
Age between 18 and 70
-
At diagnose a serum prolactin > 200 microgram/l (10 U/l)
Exclusion Criteria:
-
Hypothyroidism
-
Use of any medication
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Endocrinology | Aarhus C | Aarhus | Denmark | 8000 |
Sponsors and Collaborators
- University of Aarhus
- Aarhus University Hospital
Investigators
- Principal Investigator: Jens Otto L. Jørgensen, Professor MD, Aarhus University Hospital, Department of Endocrinology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00699530
Other Study ID Numbers:
- MM-ISP-20070132
First Posted:
Jun 18, 2008
Last Update Posted:
Dec 22, 2017
Last Verified:
Dec 1, 2014
Keywords provided by University of Aarhus
Additional relevant MeSH terms: