Obesity Clinical Trial
Official title:
Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.
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 |
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 .
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 |
Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
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 |
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