Complications of Diabetes MellitusMOMSNCT01821508
Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
A study testing Clinical Treatment and Roux-En-Y gastric bypass surgery in people with Complications of Diabetes Mellitus, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complications of Diabetes Mellitus
- What is being tested?
- Clinical Treatment and Roux-En-Y gastric bypass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Apr 2013to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Complications of Diabetes Mellitus
- Being tested
- Clinical Treatment, Roux-En-Y gastric bypass surgery
- Keywords
- Gastroplasty, Diabetes Mellitus Type II, Obesity
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical TreatmentOther
Also called lifestyle changes for obesity
metabolic surgery for diabetes and weight control
Roux-En-Y gastric bypass surgeryProcedure or surgery
laparoscopic surgical procedure with Endoscopic Surgical Stapler
| Study group | Role | What they receive |
|---|---|---|
| Clinical treatment | Active comparator | Best and most modern clinical treatment of type 2 diabetes mellitus. Receives: Other: Clinical Treatment |
| Roux-En-Y gastric bypass surgery | Active comparator | 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]. Receives: Procedure: Roux-En-Y gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12, 24 and 60 months
Secondary outcomes (8)
Changes in diabetic retinopathy
Number of patients achieving resolution or reduction in the degree of retinopathy and/or macular oedema (severity scale)
Measured: 12, 24 and 60 months
Changes in diabetic peripheral neuropathy
Number of patients with new or worsening of neuropathy
Measured: 12, 24 and 60 months
Use of pharmacological therapy for type 2 diabetes mellitus
Number of medications necessary for targeting euglycaemia
Measured: 12, 24 and 60 months
Glycemic control
Number of patients achieving fasting glucose level < 100 and HbA1c < 6.5%
Measured: 12, 24 and 60 months
Blood pressure control
Number of patients achieving systolic blood pressure <130 mm Hg and diastolic <80 mm Hg
Measured: 12, 24 and 60 months
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
Measured: 12, 24 and 60 months
Quality of life (SF-36)
SF-36 questionnaire
Measured: 12, 24 and 60 months
Changes in hepatic fibrosis
Reduction of hepatic elastographic resistance
Measured: 12, 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start18 Apr 2013
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complications of Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Alemão Oswaldo Cruz
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Principal investigator, Ricardo Vitor Cohen, MD, Hospital Alemão Oswaldo Cruz
- Investigators
- Ricardo V Cohen, MD. PhD, Principal investigator, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821508
- Sponsor's protocol ID
- MOMS
- Acronym
- MOMS
- Status last verified
- May 2021
- First submitted
- 27 Mar 2013
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cohen RV, Pereira TV, Aboud CM, Zanata Petry TB, Lopes Correa JL, Schiavon CA, Pompilio CE, Quirino Pechy FN, Calmon da Costa Silva AC, Cunha da Silveira LP, Paulo de Paris Caravatto P, Halpern H, de Lima Jacy Monteiro F, da Costa Martins B, Kuga R, Sarian Palumbo TM, Friedman AN, le Roux CW. Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial. EClinicalMedicine. 2022 Nov 11;53:101725. doi: 10.1016/j.eclinm.2022.101725. eCollection 2022 Nov.
PubMed 36467457Cohen RV, Pereira TV, Aboud CM, Petry TBZ, Lopes Correa JL, Schiavon CA, Pompilio CE, Pechy FNQ, da Costa Silva ACC, de Melo FLG, Cunha da Silveira LP, de Paris Caravatto PP, Halpern H, Monteiro FLJ, da Costa Martins B, Kuga R, Palumbo TMS, Docherty NG, le Roux CW. Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e200420. doi: 10.1001/jamasurg.2020.0420. Epub 2020 Aug 19.
PubMed 32492126Cohen RV, Pereira TV, Aboud CM, Caravatto PP, Petry TB, Correa JL, Schiavon CA, Correa M, Pompilio 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.
PubMed 28077412
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01821508
- Acronym / sponsor ID
- MOMS / MOMS
- Conditions
- Complications of Diabetes Mellitus
- Keywords
- Gastroplasty, Diabetes Mellitus Type II, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Alemão Oswaldo CruzUniversity, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical treatment | Active comparator | Other: Clinical TreatmentBest and most modern clinical treatment of type 2 diabetes mellitus. |
| Roux-En-Y gastric bypass surgery | Active comparator | Procedure: Roux-En-Y gastric bypass surgeryA "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]. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical TreatmentAlso: lifestyle changes for obesitymetabolic surgery for diabetes and weight control | Other | Clinical treatment |
| Roux-En-Y gastric bypass surgerylaparoscopic surgical procedure with Endoscopic Surgical Stapler | Procedure or surgery | Roux-En-Y gastric bypass surgery |
Primary outcome
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
8 secondary outcomes
Changes in diabetic retinopathy
Time frame: 12, 24 and 60 months
Changes in diabetic peripheral neuropathy
Time frame: 12, 24 and 60 months
Use of pharmacological therapy for type 2 diabetes mellitus
Time frame: 12, 24 and 60 months
Glycemic control
Time frame: 12, 24 and 60 months
Blood pressure control
Time frame: 12, 24 and 60 months
Lipids control
Time frame: 12, 24 and 60 months
Quality of life (SF-36)
Time frame: 12, 24 and 60 months
Changes in hepatic fibrosis
Time frame: 12, 24 and 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Derived from this study: PubMed 36467457Cohen RV, Pereira TV, Aboud CM, Zanata Petry TB, Lopes Correa JL, Schiavon CA, Pompilio CE, Quirino Pechy FN, Calmon da Costa Silva AC, Cunha da Silveira LP, Paulo de Paris Caravatto P, Halpern H, de Lima Jacy Monteiro F, da Costa Martins B, Kuga R, Sarian Palumbo TM, Friedman AN, le Roux CW. Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial. EClinicalMedicine. 2022 Nov 11;53:101725. doi: 10.1016/j.eclinm.2022.101725. eCollection 2022 Nov.
- Derived from this study: PubMed 32492126Cohen RV, Pereira TV, Aboud CM, Petry TBZ, Lopes Correa JL, Schiavon CA, Pompilio CE, Pechy FNQ, da Costa Silva ACC, de Melo FLG, Cunha da Silveira LP, de Paris Caravatto PP, Halpern H, Monteiro FLJ, da Costa Martins B, Kuga R, Palumbo TMS, Docherty NG, le Roux CW. Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e200420. doi: 10.1001/jamasurg.2020.0420. Epub 2020 Aug 19.
- Derived from this study: PubMed 28077412Cohen RV, Pereira TV, Aboud CM, Caravatto PP, Petry TB, Correa JL, Schiavon CA, Correa M, Pompilio 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo V Cohen, MD. PhD principal investigator
Hospital Alemão Oswaldo Cruz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Treatment and Roux-En-Y gastric bypass surgery in people with Complications of Diabetes Mellitus, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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: 12, 24 and 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821508, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.