Methods: A 24 week open prospective randomized controlled clinical trial including 80 adult patients (aged 40–65 years) was performed. The patients after randomization were divided into two groups: the main group followed the fast weight loss method; the control group received conventional drug treatment. The fast weight loss method included calorie restriction, salt intake, walking and sexual self-restraint. The conventional drug therapy included vitamin E, orlistat, pioglitazone hydrochloride, atorvastatin, lisinopril, benzodiazepines and anti-inflammatory agents. Primary endpoints were: ultrasound and histology suggestive of steatohepatitis, hepatic enzymes, weight loss, 2?hour oral glucose tolerance test and glycosylated hemoglobin A1C (HbA1c). Secondary endpoints were: blood pressure and lipids.
Results: A total of 83% patients completed the study. In the main group weight lost was 7–16?kg (10–20% from baseline) for 8–10 weeks. In this group weight was lost due to reduction of fat mass only. The main vs. control group showed higher decrease in fat mass from baseline (p < .001). Ultrasound imaging and liver histological scoring system evidenced significant improvement in liver steatosis/fibrosis in the main group (p < .001). In the main vs. control group weight lost at 24 weeks led to positive laboratory changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), 2?hour oral glucose tolerance test (OGTT), HbA1c, Homeostasis Model Assessment insulin resistance indexes (HOMA-IR), blood pressure (BP), cholesterol, triglycerides, bilirubin total and blood hemoglobin (p = .01). The fast weight loss in the patients adequately led to decrease in symptomatic drugs up to complete abolition.
Conclusions: The study showed benefits of the fast weight loss method improving in steatosis/fibrosis and biochemical/metabolic outcomes in patients with severe NASH and T2D. 相似文献