EFFECT OF STRUCTURED NUTRITION AND LIFESTYLE INTERVENTION ON METABOLIC, HEPATIC, AND ANTHROPOMETRIC OUTCOMES IN TYPE 2 DIABETES MELLITUS PATIENTS WITH AND WITHOUT METABOLIC DYSFUNCTION-ASSOCIATED FATTY LIVER DISEASE: A STRATIFIED RANDOMIZED CONTROLLE

Abstract

Background: Both type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated fatty liver disease (MAFLD) usually occur parallelly and share a common pathophysiological mechanism. This may include insulin resistance, dyslipidemia, and inflammation. Change in nutrition and lifestyle can help manage these conditions in a cost-effective manner. Objectives: The aim was to evaluate the effect of dietary and lifestyle intervention in patients with T2DM and MAFLD. To observe the difference in parameters like glycemic, lipid, and anthropometric profiles of subjects over the period of six months. Methods: A stratified randomized controlled trial was conducted among 300 adults with T2DM from diabetic and gastroenterology clinics in Bhubaneswar, India. Participants were categorized on the basis of the presence of MAFLD. They were randomly divided into a control group and an intervention group. Four groups with 75 participants each were created. The outcomes were measured at different intervals. It was measured at the time of start of the study and then at 1 month, 3 month, and 6 months. Results: The results were observed across all parameters in the total population. The results showed improvements over six months (p<0.001). Reduction in FBS was observed in MAFLD group. Other parameters reduced were PPBS (34.35 mg/dL), HbA1c (0.91%), ALT (21.80 U/L), AST (17.55 U/L), triglycerides (35.69 mg/dL), BMI (1.17 kg/m²), and weight (3.44 kg), with HDL rising by 4.18 mg/dL. Non-MAFLD intervention group also showed improvements, but control groups experienced only marginal changes. Intervention vs. control comparisons revealed very large effect sizes (Cohen's d: −5.05 to −5.86), with all mean differences significant at p<0.001 and 95% confidence intervals excluding zero. Conclusion: Significant improvements can be achieved with structured nutrition and lifestyle intervention in various metabolic parameters in T2DM patients. This makes a cornerstone in MAFLD and T2DM management.