Introduction: Data are lacking on the long-term effects of metabolic surgery vs medical intervention on NAFLD in patients with obesity and T2D.

Methods: A multi-center, prospective, observational study was performed with adults enrolled in the Alliance of Randomized trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) consortium. Patients with BMI 27-45 kg/m2 were randomized to medical therapy or surgery with gastric sleeve (GS), gastric band (GB), or Roux-en-Y gastric bypass (RYGB). The hepatic steatosis index (HSI), FIB-4 index, and AST-to-platelet ratio index (APRI) were calculated at baseline and follow-up at 6-15 years then compared by intention-to-treat analysis.

Results: We enrolled 262 patients, 49.9±8.3 yrs, 68.3% female, 67.2% white, HbA1c 8.5±1.5%, BMI 36.4±3.5 kg/m2. Liver steatosis was 100% positive by HSI. Fibrosis was rare by FIB-4 (<1% advanced, 16.7% at-risk) and APRI (5.0% significant or severe). Steatosis and fibrosis rates did not differ between patients when randomized to medical (N=96) or surgical (N=166) therapies (GB N=36, GS N=41, RYGB N=89). At latest follow-up, the surgical group had greater decrease in weight (-20.1 vs -11.2 kg, p<0.001), HbA1c (-1.10% vs -0.50%, p<0.001), and greater diabetes remission (16.8% vs 2.2%, p<0.001). Steatosis scores improved in both groups but to a greater extent after surgery (-8.5 vs -4.9, p<0.001). Fibrosis scores were stable even though patients were 6-15 years older and values did not differ between surgical vs medical groups (FIB-4 -0.01 vs -0.02, p=0.77; APRI -0.04 vs -0.01, p=0.60).

Conclusion: Hepatic steatosis scores improved more in patients with T2D randomized to metabolic surgery vs medical management. Fibrosis scores did not worsen as would be expected with aging, suggesting a protective effect of both surgical and medical interventions. These results support a continued role for weight loss interventions to prevent and treat NAFLD.

Disclosure

M.D.Lundholm: None. B.Hu: None. J.P.Kirwan: None. M.Patti: Consultant; MBX Biosciences, AstraZeneca, Hanmi Pharm. Co., Ltd., Other Relationship; Fractyl Health, Inc. D.E.Cummings: None. S.Kashyap: Consultant; GI Dynamics, Research Support; Fractyl Health, Inc., Stock/Shareholder; Gila therapuetics. Armms-t2d consortium: n/a.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (U01DK114156)

© 2023 by the American Diabetes Association
2023
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