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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Aarhus
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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:
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
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 September 16, 2014