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Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success
Open accessAbstract
In Brief Objective: To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. Background: There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. Methods: Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. Results: The surgery group had improved HOMA-IR (−4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P < 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P < 0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P < 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r = −0.641; P = 0.046). There were no mortalities. Conclusions: Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies. ClinicalTrials.gov ID: NCT01423877 This pilot randomized trial comparing bariatric surgery to medical weight management in patients with type 2 diabetes and BMI 30 to 35 found that surgery was very effective in improving insulin resistance and inducing diabetes remission at 6 months. We also found that sRAGE may be a good biomarker to identify which patients benefit most from surgery.
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“A short-term follow-up randomized trial examining patients with T2D demonstrated significantly improved remission of diabetes and weight loss in those individuals undergoing MBS compared with medical weight management [35].”
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“A RCT performed in a mixed population (RYGB, sleeve gastrectomy, banding) reported a weighted mean difference (WMD) of 53% (95% confidence interval, CI, 42% to 63%) excess weight loss (EWL) compared to non-operative management [34].”
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Cites
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Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes
Schauer, P. R., Bhatt, D. L., Kirwan, J. P., Wolski, K., Aminian, A., Brethauer, S. A., Navaneethan, S. D., Singh, R. P., Pothier, C. E., Nissen, S. E., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1600869 · Cited by 2,934
Benefits and Risks of Bariatric Surgery in Adults: A Review
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Eisenberg, D., Shikora, S. A., Aarts, E., Aminian, A., Angrisani, L., Cohen, R. V., de Luca, M., Faria, S. L., Goodpaster, K. P. S., Haddad, A., et al. (2023) · Obesity Surgery · doi:10.1007/s11695-022-06332-1 · Cited by 768
“A short-term follow-up randomized trial examining patients with T2D demonstrated significantly improved remission of diabetes and weight loss in those individuals undergoing MBS compared with medical weight management [35].”
Background
Metadata
- Authors
- Parikh, M., Chung, M., Sheth, S., McMacken, M., Zahra, T., Saunders, J. K., Ude-Welcome, A., Dunn, V., Ogedegbe, G., Schmidt, A. M., & Pachter, H. L.
- Affiliations
- Lincoln Medical Center (US)
- New York City Health and Hospitals Corporation (US)
- Bellevue Hospital Center (US)
- Corresponding author
- Parikh, Manish
- Chung, Mimi
- Sheth, Sheetal
- Saunders, John K.
- Pachter, H. Leon
- ORCID
- Venue
- Annals of Surgery
- Published
- 2014-10
- Volume
- 260
- Issue
- 4
- Pages
- 617-624
- ISSN
- 0003-4932 (ISSN-L)
- PMC
- PMC4691842
- OpenAlex
- W2334320614
- Cited by
- 123
- References
- 27
- Citations by year
- 2025: 8 · 2024: 5 · 2023: 19 · 2022: 8 · 2021: 13 · 2020: 16 · 2019: 11 · 2018: 10 · 2017: 8 · 2016: 19 · 2015: 6
- FWCI
- 10.90
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Annals of Surgery (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Agency for Healthcare Research and Quality (K12HS019473)
- National Center for Research Resources (UL1RR029893, KL2RR029891)
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- bariatric surgery, type 2 diabetes, diabetes remission, soluble receptor for advanced glycation end products, treatment response biomarkers, insulin resistance, HOMA-IR, HbA1c, weight loss, sleeve gastrectomy, gastric bypass, gastric band, obesity
- MeSH terms
- Receptor for Advanced Glycation End Products, Adult, Counseling, Diabetes Mellitus, Type 2, Exercise Therapy, Female, Glycated Hemoglobin, Humans, Insulin Resistance, Male, Middle Aged, Obesity, Pilot Projects, Receptors, Immunologic, Remission Induction, Biomarkers, Weight Loss, Body Mass Index, Glycation End Products, Advanced, Bariatric Surgery
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- CoChat. (2026). Citation check: Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success. https://app.cochat.ai/papers/10.1097/sla.0000000000000919
- The paper
- Parikh, M., Chung, M., Sheth, S., McMacken, M., Zahra, T., Saunders, J. K., Ude-Welcome, A., Dunn, V., Ogedegbe, G., Schmidt, A. M., & Pachter, H. L. (2014). Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success. Annals of Surgery. https://doi.org/10.1097/sla.0000000000000919
