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NCT00481299 Clinical Trial

Insulin Resistance in Women With Prolactinoma

Insulin Resistance Clinical Trial

Official title:
Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481299
Other study ID # 178/04
Secondary ID
Status Completed
Phase N/A
First received May 30, 2007
Last updated May 30, 2007
Start date October 2004
Est. completion date September 2006

Study information
Verified date April 2007
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2004
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 48 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Clementino Fraga Filho University Hospital Rio de Janeiro RJ

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

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