Clinical trial NCT02050984: Effect of Bariatric Surgery on Blood Pressure
Official title: A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Diabetes
Keywords: Obesity
Hypertension
Bariatric Surgery
Diabetes
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity and diabetes

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.


Eligibility 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.

Primary outcomes:
measure: Reduction of hypertension medication prescription
timeFrame: 12 months
Secondary outcomes:
measure: Reduction of hypertension medication prescription
timeFrame: 1 month to 6 months
Other outcomes:
measure: Change from baseline in systolic blood pressure
timeFrame: 1 to 12 months
measure: Change from baseline in diastolic blood pressure
timeFrame: 1 to 12 months
measure: Change from baseline in body weight
timeFrame: 1 to 12 months
measure: Change from baseline in body mass index
timeFrame: 1 to 12 months
measure: Change from baseline in waist circumference
timeFrame: 1 to 12 months
measure: Change from baseline in body fat distribution
timeFrame: 1 to 12 months
measure: Change from baseline in fasting plasma glucose
timeFrame: 1 to 12 months
measure: Change from baseline in fasting plasma insulin
timeFrame: 1 to 12 months
measure: Change from baseline in HbA1c
timeFrame: 3 to 12 months
measure: Change from baseline in total cholesterol
timeFrame: 1 to 12 months
measure: Change from baseline in LDL-cholesterol
timeFrame: 1 to 12 months
measure: Change from baseline in HDL-cholesterol
timeFrame: 1 to 12 months
measure: Change from baseline in triglycerides
timeFrame: 1 to 12 months
measure: Change from baseline in artery vasodilative function
timeFrame: 1 to 12 months
measure: Change from baseline in serum amino acids level
timeFrame: 1 to 12 months
measure: Change from baseline in sense of taste
timeFrame: 1 to 12 months
measure: Change from baseline in hepatic enzymes
timeFrame: 1 to 12 months
measure: Change from baseline in serum creatine
timeFrame: 1 to 12 months
measure: Change from baseline in serum electrolyte
timeFrame: 1 to 12 months
measure: Change from baseline in complete blood count
timeFrame: 1 to 12 months
measure: Adverse events
timeFrame: 1 to 12 months
Locations:
city: Chongqing
country: China
facility: The Third Military Medical University
state: Chongqing
Study officials:
References:
citation: 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.