The Effects of VEGF-B Signaling Pathway in Obesity and Me... | NCT03164005

Studies
The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease

NCT03164005

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

194Actual

Phase

Not provided

Conditions

Obesity
Metabolic Disease

Interventions

Not provided

Countries

China

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

Apr 2021

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

Apr 20, 2017Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

May 13, 2017

First Submission Date that Met QC Criteria

May 21, 2017

First Posted Date

May 23, 2017Actual

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

Apr 5, 2021

Last Update Posted Date

Apr 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Lulu, Head of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

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 investigators will enroll about 120 subjects from the hospital's healthcare center. The investigators will collect the basic informations, blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject. The investigators will collect the blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter region methylation status and the genomic protein methylation levels of the VEGF-B gene of the cells，and finally do the statistical analysis.

Detailed Description

The investigators will enroll about 120 subjects from the hospital's healthcare center, and these 120 subjects will be divided into four groups: normal weight with or without metabolic diseases and obesity with or without metabolic diseases. Each group has 30 subjects. The investigators will collect the basic information(name, gender，age, medical history，family history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject from the healthcare center. The investigators will collect the blood samples of each subject,separate the plasma and then test the fasting insulin, VEGF-B levels by ELISA. The investigators will separate the peripheral blood mononuclear cells from the blood, and then test the gene promoter region methylation status of the VEGF -B gene by PCR and the bisulfite-modified sequencing and test the genomic protein methylation level of the VEGF-B gene by chromatin immunoprecipitation assay(CHIP) and real-time quantitative PCR of the cells，and finally do the statistical analysis.

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

Retention

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		subjects without metabolic diseases
Group 2		subjects with metabolic diseases

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting insulin and blood VEGF-B levels	To investigate the relationship between blood pressure, BMI, fasting blood glucose, fasting blood lipids and fasting insulin and blood VEGF-B levels.	3 days

Secondary Outcomes

Measure	Description	Time Frame
The methylation status of VEGF-B gene promoter region and VEGF-B genomic protein methylation level .	To investigate the relationship between the methylation status of VEGF-B gene promoter region and VEGF-B genomic protein methylation level and obesity and metabolic disorders.	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

subjects without metabolic diseases , subjects with metabolic diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chen Lulu	Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei		China

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
D008659	Metabolic Diseases

Ancestor Terms

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

Browse Leaves

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Browse Branches

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