NCT01821508: MOMS

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

Completed NA Last updated 28 May 2021

What this trial tests

NA trial testing Clinical Treatment in Complications of Diabetes Mellitus in 100 participants. Completed in 29 April 2021.

Timeline

18 April 2013

Primary endpoint
29 April 2021

29 April 2021

Quick facts

Lead sponsor	Hospital Alemão Oswaldo Cruz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	18 April 2013
Primary completion	29 April 2021
Estimated completion	29 April 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Clinical Treatment — full drug profile →
• Roux-En-Y gastric bypass surgery

Conditions studied

• Complications of Diabetes Mellitus — all drugs for Complications of Diabetes Mellitus →

Sponsor

Hospital Alemão Oswaldo Cruz

Who can join

Adults 18 to 65, any sex, with Complications of Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surgery for weight loss in adults.
   Colquitt JL, Pickett K, Loveman E, Frampton GK. · · 2014 · cited 748× · PMID 25105982 · DOI 10.1002/14651858.cd003641.pub4
2. 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.
   Cohen RV, Pereira TV, Aboud CM, Petry TBZ, et al · · 2020 · cited 104× · PMID 32492126 · DOI 10.1001/jamasurg.2020.0420
3. Impact of bariatric surgery on cardiovascular and renal complications of diabetes: a focus on clinical outcomes and putative mechanisms.
   Martin WP, Docherty NG, Le Roux CW. · · 2018 · cited 34× · PMID 30231777 · DOI 10.1080/17446651.2018.1518130
4. Gastric bypass <i>versus</i> best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial.
   Cohen RV, Pereira TV, Aboud CM, Zanata Petry TB, et al · · 2022 · cited 25× · PMID 36467457 · DOI 10.1016/j.eclinm.2022.101725
5. 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.
   Cohen RV, Pereira TV, Aboud CM, Caravatto PP, et al · · 2017 · cited 18× · PMID 28077412 · DOI 10.1136/bmjopen-2016-013574
6. Characterization of the renal cortical transcriptome following Roux-en-Y gastric bypass surgery in experimental diabetic kidney disease.
   Nair M, Martin WP, Zhernovkov V, Elliott JA, et al · · 2020 · cited 11× · PMID 32747384 · DOI 10.1136/bmjdrc-2019-001113
7. Urinary Metabolomic Changes Accompanying Albuminuria Remission following Gastric Bypass Surgery for Type 2 Diabetic Kidney Disease.
   Martin WP, Malmodin D, Pedersen A, Wallace M, et al · · 2022 · cited 9× · PMID 35186675 · DOI 10.3390/metabo12020139
8. Renoprotective Effects of the Combination of Empagliflozin and Liraglutide Compared With Roux-en-Y Gastric Bypass in Early-Stage Diabetic Kidney Disease: A Post Hoc Analysis of the Microvascular Outcomes after Metabolic Surgery (MOMS) Randomized Controlled Clinical Trial.
   Cohen RV, Petry TBZ, Miras AD, Aboud CM, et al · · 2021 · cited 3× · PMID 34362818 · DOI 10.2337/dc21-1192