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Effect of Bariatric Surgery on Blood Pressure (BASBP)

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ClinicalTrials.gov Identifier: NCT02050984
Recruitment Status : Unknown
Verified January 2014 by Zhiming Zhu, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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.

Condition or disease
Obesity Diabetes

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Reduction of hypertension medication prescription [ Time Frame: 12 months ]
    Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.


Secondary Outcome Measures :
  1. Reduction of hypertension medication prescription [ Time Frame: 1 month to 6 months ]
    Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months.


Other Outcome Measures:
  1. Change from baseline in systolic blood pressure [ Time Frame: 1 to 12 months ]
  2. Change from baseline in diastolic blood pressure [ Time Frame: 1 to 12 months ]
  3. Change from baseline in body weight [ Time Frame: 1 to 12 months ]
  4. Change from baseline in body mass index [ Time Frame: 1 to 12 months ]
  5. Change from baseline in waist circumference [ Time Frame: 1 to 12 months ]
  6. Change from baseline in body fat distribution [ Time Frame: 1 to 12 months ]
  7. Change from baseline in fasting plasma glucose [ Time Frame: 1 to 12 months ]
  8. Change from baseline in fasting plasma insulin [ Time Frame: 1 to 12 months ]
  9. Change from baseline in HbA1c [ Time Frame: 3 to 12 months ]
  10. Change from baseline in total cholesterol [ Time Frame: 1 to 12 months ]
  11. Change from baseline in LDL-cholesterol [ Time Frame: 1 to 12 months ]
  12. Change from baseline in HDL-cholesterol [ Time Frame: 1 to 12 months ]
  13. Change from baseline in triglycerides [ Time Frame: 1 to 12 months ]
  14. Change from baseline in artery vasodilative function [ Time Frame: 1 to 12 months ]
    Endothelium-dependent nitroglycerin(NTG)-induced dilatation and flow-mediated dilatation (FMD) by non-invasive high-resolution ultrasound.

  15. Change from baseline in serum amino acids level [ Time Frame: 1 to 12 months ]
  16. Change from baseline in sense of taste [ Time Frame: 1 to 12 months ]
  17. Change from baseline in hepatic enzymes [ Time Frame: 1 to 12 months ]
  18. Change from baseline in serum creatine [ Time Frame: 1 to 12 months ]
  19. Change from baseline in serum electrolyte [ Time Frame: 1 to 12 months ]
  20. Change from baseline in complete blood count [ Time Frame: 1 to 12 months ]
  21. Adverse events [ Time Frame: 1 to 12 months ]

Biospecimen Retention:   Samples Without DNA
Blood sample


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: National Basic Research Program of China )
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms