Effect of Bariatric Surgery on Blood Pressure

NCT ID: NCT02050984

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhiming Zhu

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Director of the Dept. of Hypertension & Endocrinology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongbo He, MD.

Role: CONTACT

86-23-69757880

Zhiming Zhu, MD., PhD.

Role: CONTACT

86-23-68767881

Facility Contacts

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Hongbo He, MD.

Role: primary

86-23-68757880

References

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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.

Reference Type DERIVED
PMID: 33197293 (View on PubMed)

Other Identifiers

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2012CB517805

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BASBP

Identifier Type: -

Identifier Source: org_study_id

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