Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164005
Recruitment Status : Unknown
Verified May 2017 by Chen Lulu, Wuhan Union Hospital, China.
Recruitment status was:  Recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Lulu, Wuhan Union Hospital, China

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
Obesity Metabolic Disease

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 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 : April 20, 2017
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Normal weight subjects without metabolic diseases
Group 2
Normal weight subjects with metabolic diseases
Group 3
Obesity subjects without metabolic diseases
Group 4
Obesity subjects with metabolic diseases



Primary Outcome Measures :
  1. Fasting insulin and blood VEGF-B levels [ Time Frame: 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 . [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Plasma,Peripheral blood mononuclear cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obesity (BMI ≥ 28kg/m2) subjects without metabolic diseases ,or obese subjects with metabolic diseases, Or normal body weight (18.5 kg/m2 ≤ BMI <24 kg/m2) subjects without metabolic diseases, or normal body weight subjects with metabolic diseases.
Criteria

Inclusion Criteria:

  • Subjects with normal weight(18.5kg/m²≤BMI<24kg/m²)or obesity(28kg/m²≤BMI)

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164005


Contacts
Layout table for location contacts
Contact: Ye Xiaofeng +86 18086482871 yexf2016@163.com
Contact: Kong Wen +86 027-85726798 wenly-kong@163.com

Locations
Layout table for location information
China, Hubei
Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Ye Xiaofeng    +86 18086482871    yexf2016@163.com   
Contact: Kong Wen    +86 027-85726798    wenly-kong@163.com   
Sub-Investigator: Mohammad Ishraq Zafar         
Principal Investigator: Chen Lulu         
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
Layout table for investigator information
Principal Investigator: Chen Lulu Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
Layout table for additonal information
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    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chen Lulu, Wuhan Union Hospital, China:
VEGF-B
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight