Circulating Levels of Pealbumin in Relation to Overweight... | NCT04333446

Studies
Circulating Levels of Pealbumin in Relation to Overweight or Obesity

NCT04333446

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Completed

Last Update Posted

May 18, 2020Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2019Actual

Primary Completion Date

Jul 26, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Apr 1, 2020

First Submission Date that Met QC Criteria

Apr 1, 2020

First Posted Date

Apr 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2020

Last Update Posted Date

May 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gianluigi Giannelli, Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prealbumin	Prealbumin (g/L) concentration in serum	baseline
Free Triiodothyronine (FT3)	FT3 (pg/mL) concentration in serum	baseline
Parathormone (PTH)	PTH (pg/mL) concentration in serum	baseline
Triglycerides	Triglycerides (mg/dl) concentration in serum	baseline

Secondary Outcomes

Measure	Description	Time Frame
Height	Height in meters	baseline
Weight	Weight in kilograms	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luisa Lampignano		Castellana Grotte		70013	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided