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

Complications of Diabetes Mellitus Clinical Trial

— MOMS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821508
• Other study ID #: MOMS
• Status: Completed
• Phase: N/A
• Start date: April 18, 2013
• Est. completion date: April 29, 2021

Study information

• Verified date: May 2021
• Source: Hospital Alemão Oswaldo Cruz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications of Diabetes Mellitus
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Clinical Treatment
metabolic surgery for diabetes and weight control

Procedure:
• Roux-En-Y gastric bypass surgery
laparoscopic surgical procedure with Endoscopic Surgical Stapler

Locations

Country	Name	City	State
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Alemão Oswaldo Cruz	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ).	Number of participants achieving remission Titrating the relation of urinary albumin/creatinine	12, 24 and 60 months
Secondary	Changes in diabetic retinopathy	Number of patients achieving resolution or reduction in the degree of retinopathy and/or macular oedema (severity scale)	12, 24 and 60 months
Secondary	Changes in diabetic peripheral neuropathy	Number of patients with new or worsening of neuropathy	12, 24 and 60 months
Secondary	Use of pharmacological therapy for type 2 diabetes mellitus	Number of medications necessary for targeting euglycaemia	12, 24 and 60 months
Secondary	Glycemic control	Number of patients achieving fasting glucose level < 100 and HbA1c < 6.5%	12, 24 and 60 months
Secondary	Blood pressure control	Number of patients achieving systolic blood pressure <130 mm Hg and diastolic <80 mm Hg	12, 24 and 60 months
Secondary	Lipids control	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
Secondary	Quality of life (SF-36)	SF-36 questionnaire	12, 24 and 60 months
Secondary	Changes in hepatic fibrosis	Reduction of hepatic elastographic resistance	12, 24 and 60 months