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

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. Identifier: NCT00699530
Recruitment Status : Withdrawn
First Posted : June 18, 2008
Last Update Posted : December 22, 2017
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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
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

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.

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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

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 identifier (NCT number): NCT00699530

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Department of Endocrinology
Aarhus C, Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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Principal Investigator: Jens Otto L. Jørgensen, Professor MD Aarhus University Hospital, Department of Endocrinology
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Responsible Party: University of Aarhus Identifier: NCT00699530    
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:
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs