Effect of Bariatric Surgery on Blood Pressure (BASBP)

August 27, 2018 updated by: Zhiming Zhu

A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes

Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions such as diabetes. A variety of studies showed that it cause significant weight loss, recovery from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has lower BMI than that in west country. Therefore, this research is designed to observe whether bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhiming Zhu, MD., PhD.
  • Phone Number: 86-23-68767881
  • Email: zhuzm@yahoo.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • The Third Military Medical University
        • Contact:
        • Principal Investigator:
          • Zhiming Zhu, MD.,PhD.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with obesity and diabetes

Description

Inclusion Criteria:

  • Adults aged between 18 and 60 years old.
  • Type 2 Diabetes diagnosis defined according to WHO 2006 guideline.
  • Body mass index between 25.0 and 39.9 kg/m2.

Exclusion Criteria:

  • Hypertension ≥ 180/120 mmHg;
  • Type 1 diabetes, other types of diabetes or gestational diabetes;
  • Acute complications of diabetes;
  • Cerebrovascular diseases in the last 6 months.
  • Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
  • Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
  • Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min.
  • Advanced peripheral arterial disease
  • Atrophic gastritis
  • Alcoholism or use of illicit drugs
  • Previous laparotomy
  • Severe hepatic disorders
  • Pregnancy or women not using effective contraceptive methods.
  • Recent neoplasm (< 5 years)
  • Immunosuppressant drugs
  • Unable to understanding and follow the study protocol orientations.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of hypertension medication prescription
Time Frame: 12 months
Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction of hypertension medication prescription
Time Frame: 1 month to 6 months
Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.
1 month to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in systolic blood pressure
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in diastolic blood pressure
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in body weight
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in body mass index
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in waist circumference
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in body fat distribution
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in fasting plasma glucose
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in fasting plasma insulin
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in HbA1c
Time Frame: 3 to 12 months
3 to 12 months
Change from baseline in total cholesterol
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in LDL-cholesterol
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in HDL-cholesterol
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in triglycerides
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in artery vasodilative function
Time Frame: 1 to 12 months
Endothelium-dependent nitroglycerin(NTG)-induced dilatation and flow-mediated dilatation (FMD) by non-invasive high-resolution ultrasound.
1 to 12 months
Change from baseline in serum amino acids level
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in sense of taste
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in hepatic enzymes
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in serum creatine
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in serum electrolyte
Time Frame: 1 to 12 months
1 to 12 months
Change from baseline in complete blood count
Time Frame: 1 to 12 months
1 to 12 months
Adverse events
Time Frame: 1 to 12 months
1 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhiming Zhu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BASBP
  • 2012CB517805 (Other Grant/Funding Number: National Basic Research Program of China)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings