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Effect of Bariatric Surgery on Blood Pressure (BASBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT02050984
First received: January 25, 2014
Last updated: January 29, 2014
Last verified: January 2014

January 25, 2014
January 29, 2014
January 2010
December 2014   (final data collection date for primary outcome measure)
Reduction of hypertension medication prescription [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.
Same as current
Complete list of historical versions of study NCT02050984 on ClinicalTrials.gov Archive Site
Reduction of hypertension medication prescription [ Time Frame: 1 month to 6 months ] [ Designated as safety issue: No ]
Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.
Same as current
  • Change from baseline in systolic blood pressure [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in diastolic blood pressure [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in body mass index [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in body fat distribution [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma insulin [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c [ Time Frame: 3 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in total cholesterol [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-cholesterol [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in HDL-cholesterol [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in artery vasodilative function [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
    Endothelium-dependent nitroglycerin(NTG)-induced dilatation and flow-mediated dilatation (FMD) by non-invasive high-resolution ultrasound.
  • Change from baseline in serum amino acids level [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in sense of taste [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in hepatic enzymes [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatine [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum electrolyte [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in complete blood count [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
Same as current
 
Effect of Bariatric Surgery on Blood Pressure
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood sample

Non-Probability Sample

Patients with obesity and diabetes

  • Obesity
  • Diabetes
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Hongbo He, MD. 86-23-69757880 cqhehongbo@gmail.com
Contact: Zhiming Zhu, MD., PhD. 86-23-68767881 zhuzm@yahoo.com
China
 
NCT02050984
BASBP, 2012CB517805
Yes
Zhiming Zhu, Third Military Medical University
Zhiming Zhu
Not Provided
Not Provided
Third Military Medical University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP