ProlactinomaNCT00481299
Insulin Resistance in Women With Prolactinoma
An observational study of Prolactinoma and Insulin Resistance, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma. The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolactinoma, Insulin Resistance, Hyperlipidemia
- How many people
- 2,004 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2004to Sep 2006
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prolactinoma
- Female gender
- Premenopausal
Who cannot join
- Obesity (BMI ≥ 30 kg/m²)
- Diabetes mellitus
- Hypertension
- GH deficiency
- Hypothyroidism
- Primary hypogonadism
- Adrenal insufficiency
- Pituitary surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clementino Fraga Filho University Hospital
Rio de Janeiro, Rio de Janeiro
About this study
Official title: Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists
Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.
The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.
Read the detailed description
A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.
- Conditions
- Prolactinoma, Insulin Resistance, Hyperlipidemia
- Keywords
- Insulin, glucose, lipids, prolactinoma, hyperprolactinemia
- Medical subject headings
- Prolactinoma, Insulin Resistance, Hyperlipidemias, Hyperprolactinemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startOct 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 2,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Erika CO Naliato, MSc, Principal investigator, Federal University of Rio de Janeiro - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481299
- Sponsor's protocol ID
- 178/04
- Status last verified
- Apr 2007
- First submitted
- 30 May 2007
- Last updated
- 1 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists
- ClinicalTrials.gov ID
- NCT00481299
- Acronym / sponsor ID
- 178/04
- Conditions
- Prolactinoma, Insulin Resistance, Hyperlipidemia
- Keywords
- Insulin, glucose, lipids, prolactinoma, hyperprolactinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 1 Jun 2007 (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.
Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.
The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.
Detailed description
A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Prolactinoma
- Female gender
- Premenopausal
Key exclusion criteria (8 listed)
- Obesity (BMI ≥ 30 kg/m²)
- Diabetes mellitus
- Hypertension
- GH deficiency
- Hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
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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.
Erika CO Naliato, MSc principal investigator
Federal University of Rio de Janeiro - Brazil
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 Prolactinoma and Insulin Resistance, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 8 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: finished, as of the sponsor's last update on 1 Jun 2007. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 1 Jun 2007.