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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01821508
Recruitment Status : Active, not recruiting
First Posted : April 1, 2013
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Ricardo Vitor Cohen, MD, Hospital Alemão Oswaldo Cruz

Tracking Information
First Submitted Date  ICMJE March 27, 2013
First Posted Date  ICMJE April 1, 2013
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE April 18, 2013
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
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 ]
Titrating the relation of urinaryalbumin/creatinin
Change History Complete list of historical versions of study NCT01821508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Retinopathy reversal [ Time Frame: 24 months ]
    Retinoscopy
  • Development or worsening of peripheral neuropathy [ Time Frame: 24 months ]
  • Discontinuation of pharmacological therapy for T2DM [ Time Frame: 24 months ]
  • Glycemic control (fasting glucose level < 100 and HbA1c < 6.5%) [ Time Frame: 24 months ]
    Along with medication decrease/increase
  • Normalization of blood pressure (systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg) [ Time Frame: 24 months ]
    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 ]
    Decrease or medication cessation
  • Quality of life (SF-36) [ Time Frame: 12 & 24 months ]
    SF-36 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE Prospective, Open,Randomized, Unicentre 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.
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 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Complications of Diabetes Mellitus
Intervention  ICMJE
  • Other: Clinical Treatment
    metabolic surgery for diabetes and weight control
    Other Name: lifestyle changes for obesity
  • Procedure: Roux-En-Y gastric bypass surgery
    laparoscopic surgical procedure with Endoscopic Surgical Stapler
Study Arms  ICMJE
  • Active Comparator: Clinical treatment
    Best and most modern clinical treatment of type 2 diabetes mellitus.
    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 type 2 diabetes mellitus [SCHULMAN, 2009].
    Intervention: Procedure: Roux-En-Y gastric bypass surgery
Publications * Cohen RV, Pereira TV, Aboud CM, Caravatto PP, Petry TB, Correa JL, Schiavon CA, Correa M, Pompílio CE, Pechy FN, le Roux CW; MOMS Study Investigators. Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial. BMJ Open. 2017 Jan 11;7(1):e013574. doi: 10.1136/bmjopen-2016-013574. Erratum in: BMJ Open. 2017 Apr 22;7(4):e013574corr1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 10, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2013)
72
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821508
Other Study ID Numbers  ICMJE MOMS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ricardo Vitor Cohen, MD, Hospital Alemão Oswaldo Cruz
Study Sponsor  ICMJE Hospital Alemão Oswaldo Cruz
Collaborators  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Principal Investigator: Ricardo V Cohen, MD. PhD Hospital Alemão Oswaldo Cruz
PRS Account Hospital Alemão Oswaldo Cruz
Verification Date April 2019

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