We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699530
First Posted: June 18, 2008
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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 ]

Secondary Outcome Measures:
  • QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance [ Time Frame: Before and after treatment ]

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00699530     History of Changes
Other Study ID Numbers: MM-ISP-20070132
First Submitted: May 23, 2008
First Posted: June 18, 2008
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University of Aarhus:
Prolactin
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperprolactinemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Insulin
Cabergoline
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action