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Trial record 1 of 1 for:    Empty Sella Syndrome
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Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02092779
First Posted: March 20, 2014
Last Update Posted: March 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lucio Gnessi, University of Roma La Sapienza
  Purpose
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 .

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.

Resource links provided by NLM:


Further study details as provided by Lucio Gnessi, University of Roma La Sapienza:

Primary Outcome Measures:
  • Cranio-caudal pituitary diameter in millimeters [ Time Frame: Participants will be followed for the duration of day hospital stay, an expected average of 1 week ]

Secondary Outcome Measures:
  • Growth hormone releasing hormone plus arginine test for GH secretion μg/L [ Time Frame: Participants will be followed for the duration of day hospital stay, an expected average of 1 week ]

Enrollment: 447
Study Start Date: March 2007
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese patients, no treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese
Criteria

Inclusion Criteria:

  • Adult obese

Exclusion Criteria:

  • psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092779


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Lucio Gnessi, MD, PhD University of Roma La Sapienza
  More Information

Responsible Party: Lucio Gnessi, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02092779     History of Changes
Other Study ID Numbers: GHD2014
Dept.Exp.Med.Sapienza.Rome ( Other Identifier: Sapienza University of Rome )
First Submitted: March 17, 2014
First Posted: March 20, 2014
Last Update Posted: March 20, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Obesity
Dwarfism, Pituitary
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs