Effect of Bariatric Surgery on Blood Pressure (BASBP)

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: Unknown
• Conditions: Obesity; Diabetes

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • The Third Military Medical University
      • Contact: Hongbo He, MD.; Phone Number: 86-23-68757880; Email: cqhehongbo@gmail.com
      • Principal Investigator: Zhiming Zhu, MD.,PhD.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of hypertension medication prescription	Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in systolic blood pressure		1 to 12 months
Change from baseline in diastolic blood pressure		1 to 12 months
Change from baseline in body weight		1 to 12 months
Change from baseline in body mass index		1 to 12 months
Change from baseline in waist circumference		1 to 12 months
Change from baseline in body fat distribution		1 to 12 months
Change from baseline in fasting plasma glucose		1 to 12 months
Change from baseline in fasting plasma insulin		1 to 12 months
Change from baseline in HbA1c		3 to 12 months
Change from baseline in total cholesterol		1 to 12 months
Change from baseline in LDL-cholesterol		1 to 12 months
Change from baseline in HDL-cholesterol		1 to 12 months
Change from baseline in triglycerides		1 to 12 months
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
Change from baseline in serum amino acids level		1 to 12 months
Change from baseline in sense of taste		1 to 12 months
Change from baseline in hepatic enzymes		1 to 12 months
Change from baseline in serum creatine		1 to 12 months
Change from baseline in serum electrolyte		1 to 12 months
Change from baseline in complete blood count		1 to 12 months
Adverse events		1 to 12 months

Collaborators and Investigators

• Sponsor: Zhiming Zhu

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 25, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Hypertension; Bariatric Surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: BASBP; 2012CB517805 (Other Grant/Funding Number: National Basic Research Program of China)