- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164005
The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease (Obesity)
April 5, 2021 updated by: Chen Lulu, Wuhan Union Hospital, China
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
194
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
subjects without metabolic diseases , subjects with metabolic diseases
Description
Inclusion Criteria:
- NA
Exclusion Criteria:
- subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Group 1
subjects without metabolic diseases
|
Group 2
subjects with metabolic diseases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chen Lulu, Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
May 13, 2017
First Submitted That Met QC Criteria
May 21, 2017
First Posted (Actual)
May 23, 2017
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016CFA025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted