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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT03164005
Collaborator
(none)
194
Enrollment
1
Location
10.3
Actual Duration (Months)
18.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    194 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease
    Actual Study Start Date :
    Apr 20, 2017
    Actual Primary Completion Date :
    Sep 1, 2017
    Actual Study Completion Date :
    Mar 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    subjects without metabolic diseases
    Group 2

    subjects with metabolic diseases

    Outcome Measures

    Primary Outcome Measures

    1. Fasting insulin and blood VEGF-B levels [3 days]

      To investigate the relationship between blood pressure, BMI, fasting blood glucose, fasting blood lipids and fasting insulin and blood VEGF-B levels.

    Secondary Outcome Measures

    1. The methylation status of VEGF-B gene promoter region and VEGF-B genomic protein methylation level . [7 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • NA
    Exclusion Criteria:
    • subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China

    Sponsors and Collaborators

    • Wuhan Union Hospital, China

    Investigators

    • Principal Investigator: Chen Lulu, Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chen Lulu, Head of Endocrinology, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT03164005
    Other Study ID Numbers:
    • 2016CFA025
    First Posted:
    May 23, 2017
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chen Lulu, Head of Endocrinology, Wuhan Union Hospital, China
    VEGF-B
    Additional relevant MeSH terms:
    Obesity
    Metabolic Diseases

    Study Results

    No Results Posted as of Apr 8, 2021