Weight loss treatment for COVID-19 in patients with NCDs: a pilot prospective clinical trial.

COVID-19 comorbid with noncommunicable chronic diseases (NCDs) complicates the diagnosis, treatment, and prognosis, and increases the mortality rate. The aim is to evaluate the effects of a restricted diet on clinical/laboratory inflammation and metabolic profile, reactive oxygen species (ROS), and body composition in patients with COVID-19 comorbid with NCDs. We conducted a 6-week open, pilot prospective controlled clinical trial. The study included 70 adult patients with COVID-19 comorbid with type 2 diabetes (T2D), hypertension, or nonalcoholic steatohepatitis (NASH). INTERVENTIONS: a restricted diet including calorie restriction, hot water drinking, walking, and sexual self-restraint. PRIMARY ENDPOINTS: COVID-19 diagnosis by detecting SARS-CoV-2 genome by RT-PCR; weight loss in Main group; body temperature; C-reactive protein. Secondary endpoints: the number of white blood cells; erythrocyte sedimentation rate; adverse effects during treatment; fasting blood glucose, glycosylated hemoglobin A1c (HbA1c), systolic/diastolic blood pressure (BP); blood lipids; ALT/AST, chest CT-scan. In Main group, patients with overweight lost weight from baseline (- 12.4%; P < 0.0001); 2.9% in Main group and 7.2% in Controls were positive for COVID-19 (RR: 0.41, CI: 0.04-4.31; P = 0.22) on the 14th day of treatment. Body temperature and C-reactive protein decreased significantly in Main group compared to Controls on day 14th of treatment (P < 0.025). Systolic/diastolic BP normalized (P < 0.025), glucose/lipids metabolism (P < 0.025); ALT/AST normalized (P < 0.025), platelets increased from baseline (P < 0.025), chest CT (P < 0.025) in Main group at 14 day of treatment. The previous antidiabetic, antihypertensive, anti-inflammatory, hepatoprotective, and other symptomatic medications were adequately decreased to completely stop during the weight loss treatment. Thus, the fast weight loss treatment may be beneficial for the COVID-19 patients with comorbid T2D, hypertension, and NASH over traditional medical treatment because, it improved clinical and laboratory/instrumental data on inflammation; glucose/lipid metabolism, systolic/diastolic BPs, and NASH biochemical outcomes, reactive oxygen species; and allowed patients to stop taking medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT05635539 (02/12/2022): https://clinicaltrials.gov/ct2/show/NCT05635539?term=NCT05635539&draw=2&rank=1 .

Association between COVID-19 morbidity, mortality, and gross domestic product, overweight/ obesity, non-communicable diseases, vaccination rate: A cross-sectional study.

BACKGROUND: The spread of COVID-19 depends on a lot of social and economic factors. THE AIM: to study the influence of country's gross domestic product, population prevalence of overweight/ obesity, NCD mortality, and vaccination on COVID-19 morbidity and mortality rates. METHODS: A cross-sectional study with two phases: correlation-regression interrelations in 1) all world countries; 2) all world non-island countries. The study includes the following data from 218 world countries: COVID-19 morbidity/mortality rates, GDP per capita, the prevalence of overweight/ obesity, NCD mortality among adults (both sexes), people fully vaccinated against COVID-19. RESULTS: An average percentage of the prevalence of overweight among adults in world countries by 2019 was 47.31 ± 15.99%, obesity 18.34 ± 9.64%, while the prevalence by 2016 were 39% and 13%, respectively. Overweight and obesity among adults during three years grew by 21.2% and 40.8%, respectively. Data from the world countries provide significant correlations (p < 0.0001) between COVID-19 morbidity, and: GDP (r = 0.517), overweight (r = 0.54), obesity (r = 0.528), NCD mortality (r = 0.537); COVID-19 mortality, and: GDP (r = 0.344), overweight (r = 0.514), obesity (r = 0.489), NCD mortality (r = 0.611); GDP, and: overweight (r = 0.507), obesity (r = 0.523), NCD mortality (r = 0.35), fully vaccinated people (r = 0.754). An increase in fully vaccinated people, from 3% to 30% of world population, decreases new confirmed COVID-19 cases, although the dependence was not significant (p = 0.07). Data from non-island world countries provides more highly significant correlations (p < 0.0001) between COVID-19 morbidity, and: GDP (r = 0.616), overweight (r = 0.581), obesity (r = 0.583); COVID-19 mortality, and: GDP (r = 0.43), overweight (r = 0.556), obesity (r = 0.539); GDP, and: overweight (r = 0.601), obesity (r = 0.633). The differences of correlation coefficients between data of 176 world countries and data of 143 world non-island countries were not significant (Z-scores<1.29; p > 0.05). CONCLUSION: The study provides evidence of a significant impact of overweight/obesity prevalence on the increase in COVID-19 morbidity/mortality. Countries with higher GDP have a high overweight/obesity prevalence and possibility to get vaccinated.

Severe nonalcoholic steatohepatitis and type 2 diabetes: liver histology after weight loss therapy in a randomized clinical trial.

OBJECTIVE: To evaluate the effectiveness of the fast weight loss method on liver steatosis, fibrosis, inflammation, glycemic and lipid features and body composition in patients with severe nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2D). 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.