Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Hospital Alemão Oswaldo Cruz
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
MD Ricardo Victor Cohen, Hospital Alemão Oswaldo Cruz Identifier:
First received: March 27, 2013
Last updated: December 2, 2014
Last verified: December 2014

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.

Condition Intervention
Complications of Diabetes Mellitus
Other: Clinical Treatment
Procedure: Roux-En-Y gastric bypass surgery

Study Type: Interventional
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.

Resource links provided by NLM:

Further study details as provided by Hospital Alemão Oswaldo Cruz:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Retinopathy reversal [ Time Frame: 24 months ] [ Designated as safety issue: No ]

  • 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

Estimated Enrollment: 72
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clinical treatment
Best and most modern clinical treatment of T2DM.
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 T2DM [SCHULMAN, 2009].
Procedure: Roux-En-Y gastric bypass surgery
laparoscopic surgical procedure with Endoscopic Surgical Stapler

Detailed Description:
Intervention of Roux-En-Y gastric bypass surgery versus best medical treatment in control or reduces microvascular complications such as retinopathy, microalbuminuria and neuropathic.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female adult patients with microalbuminuria (more than 30 mg and less than 300 mg or more of urinary albumin per 24hours), with or without other microvascular complications of T2DM, receiving pharmacological treatment for the disease, which may or may not include the use of insulin.
  • Age between 18-65 years
  • BMI between 30 and 35 Kg/m2
  • 15-year or less after T2DM diagnosis
  • Negative anti-GAD
  • Fasting C-peptide higher than 1 ng/ml, increasing in the postprandial period (two hours after mixed meal, ENSURE plus approximately 500 Kcal)

Exclusion Criteria:

  • Patient's refusal to participate
  • Autoimmune DM (Diabetes Mellitus)
  • Previous abdominal surgeries that may make surgery more difficult, increasing the surgical risk
  • Previous malabsorptive and restrictive surgeries
  • Pregnant women and nursing mothers
  • Recent history of neoplasia (< 5 years), except for non-melanoma skin neoplasms
  • History of liver disease - liver cirrhosis -, active chronic hepatitis, active hepatitis B and hepatitis C
  • Malabsorptive syndromes and inflammatory bowel disease
  • Cardiovascular event (acute myocardial infarction, acute coronary syndrome, angioplasty, or bypass in the last 6 months)
  • Angina
  • Pulmonary embolism or severe thrombophlebitis in the last 2 years
  • Positive HIV serum testing
  • Psychiatric disorders, including dementia, active psychosis, severe depression, history of suicide attempts, use of illicit drugs, and excessive alcohol consumption in the last 12 months
  • Uncontrolled coagulopathy
  • Patients with severe retinopathy, nephropathy, and neuropathy (defined as high risk/advanced proliferative retinopathy or amaurosis; stage 5 of chronic kidney disease defined by glomerular filtration rate, patients who need dialysis or renal transplantation; stage 3 of peripheral neuropathy)
  • Patients who participated in other clinical trials in the past 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01821508

Contact: Ricardo V Cohen, MD,PhD 55 11 3549-0392
Contact: Débora G Reis, RN 55 11 3549-0392

Hospital Alemão Oswaldo Cruz Recruiting
São Paulo, Brazil, 01323-020
Contact: Débora G Reis, RN    55 11 3549-0392   
Principal Investigator: Ricardo V Cohen, MD         
Sponsors and Collaborators
Hospital Alemão Oswaldo Cruz
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Principal Investigator: Ricardo V Cohen, MD. PhD Hospital Alemão Oswaldo Cruz
  More Information

Responsible Party: MD Ricardo Victor Cohen, MD, PhD, Hospital Alemão Oswaldo Cruz Identifier: NCT01821508     History of Changes
Other Study ID Numbers: MOMS 
Study First Received: March 27, 2013
Last Updated: December 2, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Alemão Oswaldo Cruz:
Gastroplasty, Diabetes Mellitus Type II, Obesity

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2016