ObesityBASBPNCT02050984
Effect of Bariatric Surgery on Blood Pressure
An observational study of Obesity and Diabetes, run by Zhiming Zhu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with obesity and diabetes
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Hongbo He, MD., 86-23-68757880, cqhehongbo@gmail.com
Zhiming Zhu, MD.,PhD.
About this study
Official title: 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.
- Keywords
- Obesity, Hypertension, Bariatric Surgery, Diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hypertension medication prescription
Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.
Measured: 12 months
Secondary outcomes (1)
Reduction of hypertension medication prescription
Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.
Measured: 1 month to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiming Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050984
- Sponsor's protocol ID
- BASBP
- Other IDs
- 2012CB517805
- Acronym
- BASBP
- Status last verified
- Aug 2018
- First submitted
- 25 Jan 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun F, Zhou X, Li Q, Li Y, Zhang H, Yan Z, He H, Zhao Z, Ke Z, Gao Y, Li F, Tong W, Zhu Z. Achieving blood pressure targets and antihypertensive effects through metabolic surgery in type 2 diabetes patients with hypertension. Diabetes Metab Res Rev. 2021 May;37(4):e3422. doi: 10.1002/dmrr.3422. Epub 2020 Nov 30.
PubMed 33197293
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes
- ClinicalTrials.gov ID
- NCT02050984
- Acronym / sponsor ID
- BASBP / BASBP
- Keywords
- Obesity, Hypertension, Bariatric Surgery, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhiming ZhuUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with obesity and diabetes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Reduction of hypertension medication prescription
Time frame: 1 month to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 33197293Sun F, Zhou X, Li Q, Li Y, Zhang H, Yan Z, He H, Zhao Z, Ke Z, Gao Y, Li F, Tong W, Zhu Z. Achieving blood pressure targets and antihypertensive effects through metabolic surgery in type 2 diabetes patients with hypertension. Diabetes Metab Res Rev. 2021 May;37(4):e3422. doi: 10.1002/dmrr.3422. Epub 2020 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by Zhiming Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbo He, MD. (86-23-69757880, cqhehongbo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hypertension medication prescription (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.