NCT02092779

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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

7 years

First QC Date

March 17, 2014

Last Update Submit

March 18, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Cranio-caudal pituitary diameter in millimeters

    Participants will be followed for the duration of day hospital stay, an expected average of 1 week

Secondary Outcomes (1)

  • 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

Study Arms (1)

Obese patients, no treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese

You may qualify if:

  • Adult obese

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucio Gnessi, MD, PhD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

March 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 20, 2014

Record last verified: 2014-03