- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699530
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
December 21, 2017 updated by: University of Aarhus
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aarhus
-
Aarhus C, Aarhus, Denmark, 8000
- Department of Endocrinology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients recently diagnosed with hyperprolactinemia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hyperprolactinemia
Patients recently diagnosed with hyperprolactinemia
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin sensitivity
Time Frame: Before and after treatment
|
Before and after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance
Time Frame: Before and after treatment
|
Before and after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
May 23, 2008
First Submitted That Met QC Criteria
June 13, 2008
First Posted (ESTIMATE)
June 18, 2008
Study Record Updates
Last Update Posted (ACTUAL)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Hypothalamic Diseases
- Hyperinsulinism
- Hyperpituitarism
- Pituitary Diseases
- Insulin Resistance
- Hyperprolactinemia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Cabergoline
Other Study ID Numbers
- MM-ISP-20070132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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