Insulin Resistance in Women With Prolactinoma

NCT ID: NCT00481299

Last Updated: 2007-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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

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Prolactinoma Insulin Resistance Hyperlipidemia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Prolactinoma
* Female gender
* Premenopausal

Exclusion Criteria

* Obesity (BMI ≥ 30 kg/m²)
* Diabetes mellitus
* Hypertension
* GH deficiency
* Hypothyroidism
* Primary hypogonadism
* Adrenal insufficiency
* Pituitary surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Principal Investigators

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Erika CO Naliato, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio de Janeiro - Brazil

Locations

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Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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178/04

Identifier Type: -

Identifier Source: org_study_id