Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus (MOMS)
|ClinicalTrials.gov Identifier: NCT01821508|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2013
Last Update Posted : February 23, 2018
This is a prospective, open, randomized study involving 100 patients with microvascular complications of 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 type 2 diabetes mellitus. 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 type 2 diabetes mellitus 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 type 2 diabetes mellitus 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 type 2 diabetes mellitus 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 type 2 diabetes mellitus. 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.
|Condition or disease||Intervention/treatment|
|Complications of Diabetes Mellitus||Other: Clinical Treatment Procedure: Roux-En-Y gastric bypass surgery|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||March 2013|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||May 2021|
Active Comparator: Clinical treatment
Best and most modern clinical treatment of type 2 diabetes mellitus.
Other: Clinical Treatment
metabolic surgery for diabetes and weight control
Other Name: lifestyle changes for obesity
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 type 2 diabetes mellitus [SCHULMAN, 2009].
Procedure: Roux-En-Y gastric bypass surgery
laparoscopic surgical procedure with Endoscopic Surgical Stapler
- 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: 12, 24 and 60 months ]Number of participants achieving remission Titrating the relation of urinary albumin/creatinine
- Changes in diabetic retinopathy [ Time Frame: 12, 24 and 60 months ]Number of patients achieving resolution or reduction in the degree of retinopathy and/or macular oedema (severity scale)
- Changes in diabetic peripheral neuropathy [ Time Frame: 12, 24 and 60 months ]Number of patients with new or worsening of neuropathy
- Use of pharmacological therapy for type 2 diabetes mellitus [ Time Frame: 12, 24 and 60 months ]Number of medications necessary for targeting euglycaemia
- Glycemic control [ Time Frame: 12, 24 and 60 months ]Number of patients achieving fasting glucose level < 100 and HbA1c < 6.5%
- Blood pressure control [ Time Frame: 12, 24 and 60 months ]Number of patients achieving systolic blood pressure <130 mm Hg and diastolic <80 mm Hg
- Lipids control [ Time Frame: 12, 24 and 60 months ]Number of patients with LDL<100 or <70 mg/dL in patients with previous cardiovascular events; HDL>50 mg/dL and triglycerides <150 mg/dL
- Quality of life (SF-36) [ Time Frame: 12, 24 and 60 months ]SF-36 questionnaire
- Changes in hepatic fibrosis [ Time Frame: 12, 24 and 60 months ]Reduction of hepatic elastographic resistance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821508
|Hospital Alemão Oswaldo Cruz|
|São Paulo, Brazil, 01323-020|
|Principal Investigator:||Ricardo V Cohen, MD. PhD||Hospital Alemão Oswaldo Cruz|