HyperprolactinemiaNCT00699530
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
An observational study of Hyperprolactinemia and Insulin Resistance, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperprolactinemia, Insulin Resistance
- What is being tested?
- Cabergoline
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recently diagnosed with hyperprolactinemia
Who may be able to join
- Written consent
- Age between 18 and 70
- At diagnose a serum prolactin > 200 microgram/l (10 U/l)
Who cannot join
- Hypothyroidism
- Use of any medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperprolactinemia, Insulin Resistance
- Being tested
- Cabergoline
- Keywords
- Prolactin, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism
- Medical subject headings
- Hyperprolactinemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperprolactinemia | Patients recently diagnosed with hyperprolactinemia Receives: Other: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: Before and after treatment
Secondary outcomes (1)
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance
Measured: Before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Otto L. Jørgensen, Professor MD, Principal investigator, Aarhus University Hospital, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699530
- Sponsor's protocol ID
- MM-ISP-20070132
- Status last verified
- Dec 2014
- First submitted
- 23 May 2008
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
- ClinicalTrials.gov ID
- NCT00699530
- Acronym / sponsor ID
- MM-ISP-20070132
- Conditions
- Hyperprolactinemia, Insulin Resistance
- Keywords
- Prolactin, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- May 2008
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperprolactinemia | – | Other: CabergolinePatients recently diagnosed with hyperprolactinemia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recently diagnosed with hyperprolactinemia
Key inclusion criteria (3 listed)
- Written consent
- Age between 18 and 70
- At diagnose a serum prolactin > 200 microgram/l (10 U/l)
Key exclusion criteria (3 listed)
- Hypothyroidism
- Use of any medication
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabergolineCabergoline 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 | Hyperprolactinemia |
Primary outcome
Insulin sensitivity
Time frame: Before and after treatment
1 secondary outcome
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance
Time frame: Before and after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Related trials for Hyperprolactinemia
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Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
Not yet recruitingPhase 4
Carbergoline for Antipsychotic Induced Hyperprolactinemia.
Scizophrenia
Active, not recruitingPhase 1
A Study on Bioequivalence of Cabergoline Tablets in Human Body
Hyperprolactinemia
RecruitingPhase 3
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
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RecruitingPhase 4
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Prolactinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto L. Jørgensen, Professor MD principal investigator
Aarhus University Hospital, Department of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperprolactinemia and Insulin Resistance, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Before and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.