- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333446
Circulating Levels of Pealbumin in Relation to Overweight or Obesity
May 15, 2020 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Independent Relationship Between Prealbumin and Circulating Levels of Parathormone Triglycerides and FT3 in Subjects With Overweight or Obesity
The study was aimed to investigating the relationship between circulating level of prealbumin and parathormone (PTH), triglycerides and triiodothyronine (FT3) in overweight and obese subjects (BMI≥25 Kg/m2)
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Castellana Grotte, Italy, 70013
- Luisa Lampignano
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.
Description
Inclusion Criteria:
- Overweight or obesity (BMI> 25 Kg/m2)
Exclusion Criteria:
- Any kind of drug Hypertension Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), Chronic inflammatory diseases Renal failure Liver failure Angina pectoris Myocardial infarction and heart failure Genetic heart diseases Thrombocytopenias
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prealbumin
Time Frame: baseline
|
Prealbumin (g/L) concentration in serum
|
baseline
|
Free Triiodothyronine (FT3)
Time Frame: baseline
|
FT3 (pg/mL) concentration in serum
|
baseline
|
Parathormone (PTH)
Time Frame: baseline
|
PTH (pg/mL) concentration in serum
|
baseline
|
Triglycerides
Time Frame: baseline
|
Triglycerides (mg/dl) concentration in serum
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height
Time Frame: baseline
|
Height in meters
|
baseline
|
Weight
Time Frame: baseline
|
Weight in kilograms
|
baseline
|
Body mass Index (BMI)
Time Frame: baseline
|
BMI (kg/m^2)
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2019
Primary Completion (Actual)
July 26, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2020
Last Update Submitted That Met QC Criteria
May 15, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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