- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354285
24-hour Urinary Aldosterone And Endocrine System In Obesity
April 17, 2020 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.
Study Overview
Detailed Description
Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity.
Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies.
Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters.
The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.
Study Type
Observational
Enrollment (Actual)
230
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
-
-
Bari
-
Castellana Grotte, Bari, Italy, 70132
- National Institute of Gastroenterology IRCCS S. de Bellis
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
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 |
---|---|---|
Insulin
Time Frame: Baseline
|
Insulin (mIU/L) concentration in serum
|
Baseline
|
Thyroid hormones (FT3, FT4)
Time Frame: Baseline
|
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
|
Baseline
|
TSH
Time Frame: Baseline
|
TSH (mU/L) concentration in serum
|
Baseline
|
Urinary Aldosterone
Time Frame: Baseline
|
24-h Urine Aldosterone (mg/24 h)
|
Baseline
|
Prolactin
Time Frame: Baseline
|
Prolactin (ng/ml) concentration in serum
|
Baseline
|
Parathyroid Hormone
Time Frame: Baseline
|
PTH (pg/mL) concentration in serum
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D
Time Frame: Baseline
|
Vitamin D (ng/mL) concentration in serum
|
Baseline
|
Total cholesterol
Time Frame: Baseline
|
Total cholesterol (mg/dL) concentrations in serum
|
Baseline
|
HDL cholesterol
Time Frame: Baseline
|
HDL cholesterol (mg/dL) concentrations in serum
|
Baseline
|
LDL cholesterol
Time Frame: Baseline
|
LDL cholesterol (mg/dL) concentrations in serum
|
Baseline
|
BMI
Time Frame: Baseline
|
BMI (kg/m^2)
|
Baseline
|
Height
Time Frame: Baseline
|
Height in meters
|
Baseline
|
Weight
Time Frame: Baseline
|
Weight in kilograms
|
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 1, 2019
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (ACTUAL)
April 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5/2020
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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