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
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Purpose
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 | Intervention |
|---|---|
|
Hyperprolactinemia Insulin Resistance |
Other: Cabergoline |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Insulin sensitivity [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood, serum, muscle samples, fat samples
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
Other Name: Cabergoline
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients recently diagnosed with hyperprolactinemia
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699530
Contacts
| Contact: Jens Otto L. Jørgensen, Professor MD | 89-49-2025 ext +45 | joj@ki.au.dk |
| Contact: Michael Madsen, MD | 89-49-2171 ext +45 | michael.madsen@ki.au.dk |
Locations
| Denmark | |
| Department of Endocrinology | Recruiting |
| Aarhus C, Aarhus, Denmark, 8000 | |
| Principal Investigator: Jens Otto L. Jørgensen, Professor MD | |
| Sub-Investigator: Michael Madsen, MD | |
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
| Principal Investigator: | Jens Otto L. Jørgensen, Professor MD | Aarhus University Hospital, Department of Endocrinology |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00699530 History of Changes |
| Other Study ID Numbers: | MM-ISP-20070132 |
| Study First Received: | May 23, 2008 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Prolactin Insulin resistance Glucose tolerance Body Composition Substrate metabolism |
Additional relevant MeSH terms:
|
Hyperprolactinemia Insulin Resistance Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Insulin |
Cabergoline Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013