Diabetes, Obesity
Conditions
Keywords
Obesity, Hypertension, Bariatric Surgery, 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.
Interventions
None listed
Sponsors
Zhiming Zhu
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of hypertension medication prescription | 12 months | Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of hypertension medication prescription | 1 month to 6 months | Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 systolic blood pressure | 1 to 12 months | — |
| Change from baseline in triglycerides | 1 to 12 months | — |
| Change from baseline in artery vasodilative function | 1 to 12 months | 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 | 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 | — |
| Change from baseline in HDL-cholesterol | 1 to 12 months | — |
| Change from baseline in diastolic blood pressure | 1 to 12 months | — |
Countries
China
Contacts
Primary ContactHongbo He, MD.
Backup ContactZhiming Zhu, MD., PhD.
Outcome results
None listed