Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
This is a prospective, open, randomized study involving 72 patients with microvascular complications of T2DM (Type 2 Diabetes Mellitus) and obesity, who will undergo gastric bypass (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm).
The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2.
The medical community is confronted with many different studies using various methodologies to investigate the best pharmacological treatment for T2DM. The treatment algorithm offers several different options according to the stage of the disease (which is different in each study). In addition, new drugs are being developed over the years, but are not always a guarantee of effective T2DM control [MENDES, 2010]. Furthermore, these drugs do not prevent the development of this disease, consequently increasing the risks of microvascular and macrovascular complications.
Conversely, there is considerable evidence that surgery can be an adequate tool to promote T2DM remission in patients who are unresponsive to clinical treatment. Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its effects on microvascular and macrovascular complications of T2DM have not been established. Specialists suggest that the rapid and uncontrollable decrease in blood glucose adds to the concern that the surgery may paradoxically cause exacerbation of microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose before gastric bypass surgery may prevent this paradoxical worsening, leading to an interruption of this process, or even retinopathy, nephropathy, and neuropathy remission.
However, there are no studies comparing the results of these two types of treatment (clinical vs. surgical) in a similar population and assessing the development of microvascular complications of T2DM. Therefore, in order to clarify such doubts, it is necessary and extremely desirable to conduct a randomized controlled trial comparing gastric bypass with the best and most modern clinical treatment. Its findings could have a direct impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment as a safe and feasible therapeutic option for a significant portion of these patients.
Complications of Diabetes Mellitus
Other: Clinical Treatment
Procedure: Roux-En-Y gastric bypass surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Open,Randomized, Unicenter Study Comparing Roux-en-Y Gastric Bypass With the Best Clinical Treatment Regarding Improvement of Microvascular Complications of Type 2 Diabetes Mellitus in Obese Patients.|
- The primary endpoint will be the proportion of patients that present normalization of the albumin/creatinine ratio in isolated urine samples (normal value considered as an albumin/creatinine ratio of less than 30 μg/mg ). [ Time Frame: 24 months ] [ Designated as safety issue: No ]Titrating the relation of urinary albumin/creatinine
- Retinopathy reversal [ Time Frame: 24 months ] [ Designated as safety issue: No ]Retinoscopy
- Development or worsening of peripheral neuropathy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Discontinuation of pharmacological therapy for T2DM [ Time Frame: 24 months ] [ Designated as safety issue: No ]It will be measured as no antidiabetic medication taken ( no pills or insulin)
- Glycemic control (fasting glucose level < 100 and HbA1c < 6.5%) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Along with medication decrease/increase
- Normalization of blood pressure (systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Decrease or medication cessation
- Normalization of lipids (LDL < 100 mg/dL and < 70 mg/dL in patients with cardiovascular disease; HDL > 50 mg/dL, triglycerides < 150 mg/dL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Decrease or medication cessation
- Quality of life (SF-36) [ Time Frame: 12 & 24 months ] [ Designated as safety issue: No ]SF-36 questionnaire
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Clinical treatment
Best and most modern clinical treatment of T2DM.
|Other: Clinical Treatment|
Active Comparator: Roux-En-Y gastric bypass surgery
A "metabolic" surgery consists of any surgical procedure in which there is any anatomical alteration in the gastrointestinal tract by means of a diversion of food passage, resulting in improved metabolic control in patients with T2DM [SCHULMAN, 2009].
|Procedure: Roux-En-Y gastric bypass surgery|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821508
|Contact: Ricardo V Cohen, MD,PhD||55 11 firstname.lastname@example.org|
|Contact: Débora G Reis, RN||55 11 email@example.com|
|Hospital Alemão Oswaldo Cruz||Recruiting|
|São Paulo, Brazil, 01323-020|
|Contact: Débora G Reis, RN 55 11 3549-0392 firstname.lastname@example.org|
|Principal Investigator: Ricardo V Cohen, MD|
|Principal Investigator:||Ricardo V Cohen, MD. PhD||Hospital Alemão Oswaldo Cruz|