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

NCT ID: NCT02092779

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 447 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2014-03-31

Brief 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 .

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obese patients, no treatment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult obese

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lucio Gnessi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucio Gnessi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Other Identifiers

Dept.Exp.Med.Sapienza.Rome

Identifier Type: OTHER

Identifier Source: secondary_id

GHD2014

Identifier Type: -

Identifier Source: org_study_id