Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study

Obesity Clinical Trial

Official title:

Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092779
• Other study ID #: GHD2014
• Secondary ID: Dept.Exp.Med.Sap
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 18, 2014
• Start date: March 2007
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial Summary

Obesity is a disease not always attributable to nutritional imbalance, frequently associated with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to explore pituitary morphology and its association with pituitary function and metabolic phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease in a cross-sectional .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult obese

Exclusion Criteria:

• psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cranio-caudal pituitary diameter in millimeters		Participants will be followed for the duration of day hospital stay, an expected average of 1 week	No
Secondary	Growth hormone releasing hormone plus arginine test for GH secretion µg/L		Participants will be followed for the duration of day hospital stay, an expected average of 1 week	No