ObesityNCT02092779
Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study
An observational study of Obesity, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese
Who may be able to join
- Adult obese
Who cannot join
- psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function
About this study
Official title: Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.
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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients, no treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranio-caudal pituitary diameter in millimeters
Measured: 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
Measured: Participants will be followed for the duration of day hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucio Gnessi, University of Roma La Sapienza
- Investigators
- Lucio Gnessi, MD, PhD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092779
- Sponsor's protocol ID
- GHD2014
- Other IDs
- Dept.Exp.Med.Sapienza.Rome
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT02092779
- Acronym / sponsor ID
- GHD2014
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients, no treatment | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese
Key inclusion criteria (1 listed)
- Adult obese
Key exclusion criteria (1 listed)
- psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucio Gnessi, MD, PhD principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.