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.

Accumulated substancies and calorific capacity in adipose tissue: Physical and chemical clinical trial.

AIM: To study physical and chemical structures and properties including calorific value of human adipose tissue in different anatomical location in autopsy-assigned clinical trial. METHODS: A pilot physical and chemical descriptive randomized autopsy-assigned trial. Adipose tissue 252 sampled from 36 individuals at autopsy who between 36 and 63 years old died from road accidents. Interventions: Chemical functional groups and calorific value were studied using infrared and atomic adsorptive spectrometries, elemental chemical analysis and differential scanning calorimetry. Adipose tissue was sampled from the 7 various anatomical locations. RESULTS: The highest levels of the analysed chemical substancies were found in dense atherosclerotic plaque. Dense atherosclerotic plaque contains the most of metabolic products, organic and inorganic elements. Dense atherosclerotic plaque has the most of calorific value. The lowest calorific capacity has a pararenal fat. CONCLUSIONS: Human body lipids serve as a harbor for various organic substances, they may absorb different metabolic products, and they have different calorific capacity depending on their location and forms. Atherosclerotic plaque contains the most of organic and inorganic elements, and brings the highest energy potential.

Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial.

BACKGROUND: The prevalence of type 2 diabetes is increasing in worldwide despite the development of new treatment methods. Aim of the study was to evaluate a weight loss method on body composition, glycemic, lipid and hormone profiles, blood pressure and reactive oxygen species in people with treated type 2 diabetes. METHODS: A 24-week open, prospective, randomized, controlled clinical trial including 272 adult patients with treated type 2 diabetes was performed. The patients were divided in two groups: Main group consisted of 208 patients who followed a method including a calorie restriction diet and optimal physical activity; Control included 64 patients who received conventional drug treatment with weight loss. Main Outcome Measures were weight loss, fasting glucose and 2-hour oral glucose tolerance test (OGTT), HbA1c. Secondary endpoints were blood pressure, lipid and insulin blood levels. RESULTS: At 24 weeks, patients in Main weight lost between 8-18 kg (10-21%); their body mass index significantly decreased (-4.2 kg/m2) as well as their waist circumference (-13 cm) compared to Control. In Main weight loss was achieved fatty mass reduction. In Main fasting glucose and OGTT, HbA1c, blood pressure, reactive oxygen species decreased significantly, whereas hemoglobin levels and heel bone mineral density increased. In Main blood insulin levels decreased by 72.0%, cortisol levels decreased by 40.7%, while testosterone levels in men increased by 2.4 times from baseline. The application of the weight loss method led to a decrease in drug doses leading to their complete withdrawal. CONCLUSIONS: The results of this study show the beneficial role of a weight loss method in improving glycemic, lipid and hormone profiles, electrolyte and biochemical indices, blood pressure, reactive oxygen species and bone mineral density in patients with treated type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02503865. Retrospectively registered November 2015.

Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial.

BACKGROUND: The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. METHODS: A randomized controlled prospective clinical trial including 97 people, from them 71 patients with various AS manifestations. Patients were divided in 2 subgroups for non-drug weight loss program, and conventional drug therapy. The weight loss program included calorie restriction with 100-150 kcal/day, fat-free vegetables, salt diet, and optimum physical activity. Statistical analysis was performed using SPSS for Windows version 17.0. RESULTS: The weight loss subgroup lost ranging between 7-20% from an initial weight (P = 0.016). Weight loss was achieved due to fatty mass reduction only (P = 0.005). Hemoglobin levels (P < 0.001), bone mineral density (P < 0.001), percentages of water (P = 0.006) and muscle masses (P = 0.0038) were increased in weight loss subgroup. Ejection fraction (P < 0.0001), systolic output (P < 0.0001) were increased in patients with coronary artery disease. The weight loss program led to a decrease in symptomatic drugs doses up to total abolition. A conception of AS was developed. CONCLUSIONS: The weight loss program treated the AS diseases; improved laboratory and instrumental parameters, decreased symptomatic drugs doses. AS development is a logical way of ontogenetic ageing of body fat. TRIAL INTERNATIONAL REGISTRATION: ClinicalTrials.gov NCT01700075. TRIAL NATIONAL REGISTRATION: State registration is # 0109RK000079, code is O.0475 at the National Center for Scientific and Technical Information of the Republic of Kazakhstan.

Weight change therapy as a potential treatment for end-stage ovarian carcinoma.

PATIENT: Female, 41 FINAL DIAGNOSIS: Ovarian carcinoma Symptoms: Ascites • hepatomegaly • weight loss MEDICATION: - Clinical Procedure: - Specialty: Oncology. OBJECTIVE: Unusual or unexpected effect of treatment. BACKGROUND: The aim of this case report is to present the results of treatment of end-stage ovarian carcinoma in a 41-year-old women using weight loss therapy. CASE REPORT: We describe the case of a female aged 41 years with epithelial invasive ovarian cancer of III-IV stage, T3N2M1. Concurrent diseases were: abdominal carcinomatosis; hepatomegaly; ascites; condition after laparocentesis and skin-abdominal fistula; condition after 6 courses of neo-adjuvant polychemotherapy; hypertension II stage, risk factor of 3-4; dyslipidemia; and metabolic syndrome. A weight loss method based on a very-low-calorie diet and physical activity was used. Body weight was reduced from 74 kg to 53 due to loss of adipose tissue after 6 months of therapy. At the same time, the percentages of water and muscle tissue were increased significantly. While overweight was reducing, clinical, laboratory, and instrumental results were improving. As a result of the weight loss therapy, about ≈100 mm-sized ovarian cancer was transformed into smaller-sized ovarian cysts. CONCLUSIONS: An analgesic effect was also achieved without use of narcotic or non-narcotic analgesics. These cyto-reversible processes were documented by laboratory and instrumental data. The mechanisms behind these differences remain to be elucidated. Future research with a larger study cohort and longer follow-up is needed to further investigate the role of caloric restriction diet in cancer cell changes in ovarian cancer.