NCT04354285

Brief Summary

The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 17, 2020

Last Update Submit

April 17, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

  • Thyroid hormones (FT3, FT4)

    FT3 (pg/mL), FT4 (pg/mL) concentration in serum

    Baseline

  • TSH

    TSH (mU/L) concentration in serum

    Baseline

  • Urinary Aldosterone

    24-h Urine Aldosterone (mg/24 h)

    Baseline

  • Prolactin

    Prolactin (ng/ml) concentration in serum

    Baseline

  • Insulin

    Insulin (mIU/L) concentration in serum

    Baseline

  • Parathyroid Hormone

    PTH (pg/mL) concentration in serum

    Baseline

Secondary Outcomes (7)

  • Total cholesterol

    Baseline

  • HDL cholesterol

    Baseline

  • LDL cholesterol

    Baseline

  • BMI

    Baseline

  • Height

    Baseline

  • +2 more secondary outcomes

Interventions

ObservationalOTHER

Observational

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Overweight or obesity (BMI\> 25 Kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70132, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)