Status:
COMPLETED
Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Hospital Alemão Oswaldo Cruz
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Complications of Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
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.
Eligibility Criteria
Inclusion
- Male and female adult patients with microalbuminuria (more than 30 mg and less than 300 mg or more of urinary albumin per 24 hours), with or without other microvascular complications of type 2 diabetes mellitus, 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 type 2 diabetes mellitus diagnosis
- Negative anti-glutamic acid decarboxylase
- Fasting C-peptide higher than 1 ng/ml, increasing in the postprandial period (two hours after mixed meal, ENSURE plus approximately 500 Kcal)
Exclusion
- Patient's refusal to participate
- Autoimmune 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.
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01821508
Start Date
April 18 2013
End Date
April 29 2021
Last Update
May 28 2021
Active Locations (1)
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1
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01323-020