Abstract
BACKGROUND: Type 2 diabetes (T2D) is closely linked to metabolic dysfunction-associated steatotic liver disease (MASLD). However, the burden of clinically significant and advanced liver fibrosis, including cirrhosis, from community-based Indian populations remains poorly defined, with most prior studies limited by small size, referral bias, or single-centre design. METHODS: The DiaFib-Liver Study was a cross-sectional investigation conducted between January and July 2024 across multiple centres in India. Consecutive adults with T2D, asymptomatic for liver disease, who had undergone vibration-controlled transient elastography (VCTE) within the preceding six months were enrolled by diabetologists and endocrinologists across India. Patients with competing liver diseases or hepatology referrals were excluded. Liver stiffness measurement (LSM) thresholds defined clinically significant fibrosis (≥8.0 kPa), advanced fibrosis (≥10.0 kPa), and probable cirrhosis (≥15.0 kPa). Hepatic steatosis was assessed using the controlled attenuation parameter (CAP), with CAP ≥248 dB/m used to define steatosis. Predictors of clinically significant fibrosis were assessed with multivariable logistic regression. FINDINGS: A total of 9202 adults with T2D were included (mean age 53.3 years [SD 11.8]; 61% [5617/9202] male). Overall, 26% (2433/9202) had clinically significant fibrosis, 14% (1289/9202) advanced fibrosis, and 5% (491/9202) had LSM values consistent with probable cirrhosis (≥15.0 kPa). Among participants with CAP data, 65% (5289/8136) had CAP-defined hepatic steatosis (CAP ≥248 dB/m). Importantly, 13% (370/2847) of patients without steatosis (CAP <248 dB/m) already had clinically significant fibrosis, including 4% (107/2847) with probable cirrhosis (LSM ≥15.0 kPa). Independent predictors of clinically significant fibrosis included obesity (OR 1.98, 95% CI 1.80-2.19), dyslipidaemia (OR 1.21, 95% CI 1.10-1.34), reduced eGFR (OR 1.23, 95% CI 1.02-1.49), and diabetes duration ≥10 years (OR 1.12, 95% CI 1.00-1.24). Regional variation was evident, with prevalence ranging from 21% (256/1241) in central to 30% (643/2126) in southern India. Among non-obese patients (BMI <25), 19% (752/3996) had clinically significant fibrosis, with age as the only independent predictor. INTERPRETATION: One in four adults with T2D in India has clinically significant liver fibrosis and one in twenty already has probable cirrhosis based on elastography thresholds, establishing advanced liver disease as a "fourth major complication" of diabetes. Fibrosis-not steatosis-should be the focus of systematic assessment in diabetes care. These findings highlight the urgent need to integrate fibrosis screening into national diabetes programs. Prospective outcome studies and cost-effectiveness analyses are warranted to inform strategies for MASLD in T2D. FUNDING: This study did not receive any funding.