Effect of Bariatric Surgery on Blood Pressure

• Conditions: Diabetes; Obesity

• Registration Number: NCT02050984
• Lead Sponsor: Zhiming Zhu

Brief 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. 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

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-01-25
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of hypertension medication prescription	12 months	Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Reduction of hypertension medication prescription	1 month to 6 months	Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.

Trial Locations

Locations (1)

The Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China