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:
Information provided by (Responsible Party):
Lucio Gnessi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02092779
First received: March 17, 2014
Last updated: March 18, 2014
Last verified: March 2014
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02092779

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

No publications provided

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
Study First Received: March 17, 2014
Last Updated: March 18, 2014
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on September 30, 2014