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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
  Purpose

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.


Condition
Obesity
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Blood sample


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with obesity and diabetes

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050984

Contacts
Contact: Hongbo He, MD. 86-23-69757880 cqhehongbo@gmail.com
Contact: Zhiming Zhu, MD., PhD. 86-23-68767881 zhuzm@yahoo.com

Locations
China, Chongqing
The Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Hongbo He, MD.    86-23-68757880    cqhehongbo@gmail.com   
Principal Investigator: Zhiming Zhu, MD.,PhD.         
Sponsors and Collaborators
Zhiming Zhu
  More Information

No publications provided

Responsible Party: Zhiming Zhu, Director of the Dept. of Hypertension & Endocrinology, Third Military Medical University
ClinicalTrials.gov Identifier: NCT02050984     History of Changes
Other Study ID Numbers: BASBP, 2012CB517805
Study First Received: January 25, 2014
Last Updated: January 29, 2014
Health Authority: China: Ministry of Health

Keywords provided by Third Military Medical University:
Obesity
Hypertension
Bariatric Surgery
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014