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

May 27, 2021 updated by: Ricardo Vitor Cohen, MD, Hospital Alemão Oswaldo Cruz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01323-020
        • Hospital Alemao Oswaldo Cruz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12, 24 and 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12, 24 and 60 months
Changes in diabetic peripheral neuropathy
Time Frame: 12, 24 and 60 months
Number of patients with new or worsening of neuropathy
12, 24 and 60 months
Use of pharmacological therapy for type 2 diabetes mellitus
Time Frame: 12, 24 and 60 months
Number of medications necessary for targeting euglycaemia
12, 24 and 60 months
Glycemic control
Time Frame: 12, 24 and 60 months
Number of patients achieving fasting glucose level < 100 and HbA1c < 6.5%
12, 24 and 60 months
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
12, 24 and 60 months
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
12, 24 and 60 months
Quality of life (SF-36)
Time Frame: 12, 24 and 60 months
SF-36 questionnaire
12, 24 and 60 months
Changes in hepatic fibrosis
Time Frame: 12, 24 and 60 months
Reduction of hepatic elastographic resistance
12, 24 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Alemão Oswaldo Cruz

Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

  • Principal Investigator: Ricardo V Cohen, MD. PhD, Hospital Alemao Oswaldo Cruz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2013

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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