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 2012 by Hospital Alemão Oswaldo Cruz
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
MD Ricardo Victor Cohen, Hospital Alemão Oswaldo Cruz
ClinicalTrials.gov Identifier:
NCT01821508
First received: March 27, 2013
Last updated: April 12, 2013
Last verified: December 2012

March 27, 2013
April 12, 2013
March 2013
April 2014   (final data collection date for primary outcome measure)
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
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 urinaryalbumin/creatinin
Complete list of historical versions of study NCT01821508 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
  • 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
Not Provided
Not Provided
 
Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Complications of Diabetes Mellitus
  • Other: Clinical Treatment
  • Procedure: Roux-En-Y gastric bypass surgery
  • Active Comparator: Clinical treatment
    Best and most modern clinical treatment of T2DM.
    Intervention: 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].
    Intervention: Procedure: Roux-En-Y gastric bypass surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
April 2015
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Ricardo V Cohen, MD,PhD 55 11 3549-0392 rvcohen@mac.com
Contact: Débora G Reis, RN 55 11 3549-0392 debora.reis@haoc.com.br
Brazil
 
NCT01821508
MOMS
Not Provided
MD Ricardo Victor Cohen, Hospital Alemão Oswaldo Cruz
Hospital Alemão Oswaldo Cruz
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Principal Investigator: Ricardo V Cohen, MD. PhD Hospital Alemão Oswaldo Cruz
Hospital Alemão Oswaldo Cruz
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP