Effect of Bariatric Surgery on Blood Pressure

Obesity Clinical Trial

— BASBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02050984
• Other study ID #: BASBP
• Secondary ID: 2012CB517805
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Third Military Medical University
• Contact: Hongbo He, MD.
• Phone: 86-23-69757880
• Email: cqhehongbo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity

Locations

Country	Name	City	State
China	The Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiming Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in systolic blood pressure		1 to 12 months
Other	Change from baseline in diastolic blood pressure		1 to 12 months
Other	Change from baseline in body weight		1 to 12 months
Other	Change from baseline in body mass index		1 to 12 months
Other	Change from baseline in waist circumference		1 to 12 months
Other	Change from baseline in body fat distribution		1 to 12 months
Other	Change from baseline in fasting plasma glucose		1 to 12 months
Other	Change from baseline in fasting plasma insulin		1 to 12 months
Other	Change from baseline in HbA1c		3 to 12 months
Other	Change from baseline in total cholesterol		1 to 12 months
Other	Change from baseline in LDL-cholesterol		1 to 12 months
Other	Change from baseline in HDL-cholesterol		1 to 12 months
Other	Change from baseline in triglycerides		1 to 12 months
Other	Change from baseline in artery vasodilative function	Endothelium-dependent nitroglycerin(NTG)-induced dilatation and flow-mediated dilatation (FMD) by non-invasive high-resolution ultrasound.	1 to 12 months
Other	Change from baseline in serum amino acids level		1 to 12 months
Other	Change from baseline in sense of taste		1 to 12 months
Other	Change from baseline in hepatic enzymes		1 to 12 months
Other	Change from baseline in serum creatine		1 to 12 months
Other	Change from baseline in serum electrolyte		1 to 12 months
Other	Change from baseline in complete blood count		1 to 12 months
Other	Adverse events		1 to 12 months
Primary	Reduction of hypertension medication prescription	Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.	12 months
Secondary	Reduction of hypertension medication prescription	Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.	1 month to 6 months