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Insulin Resistance in Women With Prolactinoma

This study has been completed.
Sponsor:
Information provided by:
Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00481299
First received: May 30, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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
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

No publications provided

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

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

Additional relevant MeSH terms:
Hyperlipidemias
Insulin Resistance
Prolactinoma
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose 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
Dopamine Agonists
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013