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Insulin Resistance in Women With Prolactinoma
This study has been completed.
Sponsored by: Federal University of Rio de Janeiro
Information provided by: Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00481299
  Purpose

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
Prolactinoma
Insulin Resistance
Hyperlipidemia

Drug Information available for: Insulin Dopamine Dopamine hydrochloride Dextrose Lipids
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists

Further study details as provided by Federal University of Rio de Janeiro:

Enrollment: 2004
Study Start Date: October 2004
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481299

Locations
Brazil, RJ
Clementino Fraga Filho University Hospital
Rio de Janeiro, RJ, Brazil
Sponsors and Collaborators
Federal University of Rio de Janeiro
Investigators
Principal Investigator: Erika CO Naliato, MSc Federal University of Rio de Janeiro - Brazil
  More Information

Study ID Numbers: 178/04
Study First Received: May 30, 2007
Last Updated: May 30, 2007
ClinicalTrials.gov Identifier: NCT00481299  
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:
Insulin
glucose
lipids
prolactinoma
hyperprolactinemia

Study placed in the following topic categories:
Hypothalamic Diseases
Hyperlipidemias
Metabolic Diseases
Pituitary Diseases
Endocrine System Diseases
Central Nervous System Diseases
Prolactinoma
Pituitary Neoplasms
Brain Diseases
Insulin
Hyperinsulinism
Dopamine
Galactorrhoea-Hyperprolactinaemia
Hyperprolactinemia
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Adenoma
Dyslipidemias
Lipid Metabolism Disorders
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Hypoglycemic Agents
Neoplasms by Site
Neoplasms by Histologic Type
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009