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

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ClinicalTrials.gov Identifier: NCT00699530
Recruitment Status : Withdrawn
First Posted : June 18, 2008
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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
Hyperprolactinemia Insulin Resistance Other: Cabergoline

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 2008
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016


Group/Cohort 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.




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Before and after treatment ]

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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


Locations
Denmark
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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00699530     History of Changes
Other Study ID Numbers: MM-ISP-20070132
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: December 22, 2017
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