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Insulin Resistance in Women With Prolactinoma

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ClinicalTrials.gov Identifier: NCT00481299
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : June 1, 2007
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro

Study Description
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Brief 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 control and anthropometry on their metabolic profile.


Condition or disease
Prolactinoma Insulin Resistance Hyperlipidemia

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
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Study Type : Observational
Actual Enrollment : 2004 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists
Study Start Date : October 2004
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00481299


Locations
Brazil
Clementino Fraga Filho University Hospital
Rio de Janeiro, RJ, Brazil
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Erika CO Naliato, MSc Federal University of Rio de Janeiro - Brazil
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00481299     History of Changes
Other Study ID Numbers: 178/04
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: April 2007

Keywords provided by Universidade Federal do Rio de Janeiro:
Insulin
glucose
lipids
prolactinoma
hyperprolactinemia

Additional relevant MeSH terms:
Insulin Resistance
Hyperlipidemias
Hyperlipoproteinemias
Prolactinoma
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs