NCT00481299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

June 1, 2007

Status Verified

April 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

ProlactinomaInsulin ResistanceHyperlipidemia

Keywords

Insulinglucoselipidsprolactinomahyperprolactinemia

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Prolactinoma
  • Female gender
  • Premenopausal

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

ProlactinomaInsulin ResistanceHyperlipidemiasHyperprolactinemia

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SitePituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHyperpituitarism

Study Officials

  • Erika CO Naliato, MSc

    Federal University of Rio de Janeiro - Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

October 1, 2004

Study Completion

September 1, 2006

Last Updated

June 1, 2007

Record last verified: 2007-04

Locations

BR(1)