Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to evaluate the effects of the fast weight loss on clinic and laboratory inflammation profile, metabolic profile, reactive oxygen species (ROS) and body composition in patients with COVID and Influenza in comorbidity with NCDs. Primary endpoints: Clinic/infectious/inflammation tests for COVID and Influenza; weight loss during 14 days. Secondary endpoints: fasting blood glucose, HbA1c, blood insulin; systolic/diastolic BP; blood lipids; ALT, AST, chest CT-scan.

Detailed Description
-----------------
Study Design. A 6-week, open, pilot prospective clinical trial with the intention-to-treat principle. Participants: The study enrolled 72 adult people (38 women) aged from 25 to 80 years with moderate-to-severe cases COVID and Influenza in comorbidity with NCDs as T2D, hypertension, and NASH. All patients with the ARDs had in comorbidity with one or more NCDs. All patients refused for pharmacology therapy due to: either previous unsuccessful drug results; or an antimicrobial resistance profile; or drug allergy; or reluctance to take medication; or iatrogenic fear (iatrophobia); or a rich failed experience in drug treatment; and NASH. All the patients were admitted into the out-patient department in 3-5 days after illness onset. The study was carried out in the Republic of Kazakhstan from November, 2020, through July, 2022 at University Medical Center (Astana) and ANADETO medical center.

Official Title
-----------------
A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.

Conditions
-----------------
Clinical Trial

Intervention / Treatment
-----------------
* Dietary Supplement: Analimentary detoxication (ANADETO) weight loss based on very-low-calorie-diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent form; patients with fever patients refused for pharmacology therapy weight loss treatment for 12-14 days and +4 weeks follow-up (total 6 weeks) Exclusion Criteria: patients with acute respiratory failure and assisted ventilation requirement respiratory rate ≥ 30 times per minute oxygen saturation ≤ 93% by finger oximetry at resting status

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 27 patients with COVID and 35 patients with Influenza
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with COVID<br>27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH | Dietary Supplement: Analimentary detoxication (ANADETO) weight loss based on very-low-calorie-diet<br>* calorie restriction to 50-100 kcal/day with fat-free vegetables (tomatoes and cucumbers) with mandatory salt intake to 5-6 gr/day, hot water drinking 1000-1500 ml/day, walking at least 2,000 steps/day after normalized body temperature, and sexual self-restraint. The walking provided to promote of blood circulation and decrease in metabolic intoxication. The weight loss method lasted 14 days. Then the patients followed for 4-week a diet where they ate one meal a day without any food restriction.<br>* Other names: very-low-calorie-diet;|
| Experimental: patients with Influenza<br>35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH | Dietary Supplement: Analimentary detoxication (ANADETO) weight loss based on very-low-calorie-diet<br>* calorie restriction to 50-100 kcal/day with fat-free vegetables (tomatoes and cucumbers) with mandatory salt intake to 5-6 gr/day, hot water drinking 1000-1500 ml/day, walking at least 2,000 steps/day after normalized body temperature, and sexual self-restraint. The walking provided to promote of blood circulation and decrease in metabolic intoxication. The weight loss method lasted 14 days. Then the patients followed for 4-week a diet where they ate one meal a day without any food restriction.<br>* Other names: very-low-calorie-diet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic and infectious tests for COVID and Influenza | COVID was diagnosed primarily by direct detection of SARS-CoV-2 RNA by nucleic acid amplification tests with a real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay. To diagnosis of the flu was used a RT-PCR test called the Flu SC2 Multiplex Assay. | Change from Baseline at 6 Weeks | 
| weight loss during 14 days | kg | Change from Baseline at 14 days | 
| C-reactive protein | mg/L | Change from Baseline at 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose | mmol/L | Change from Baseline at 6 Weeks | 
| glycosylated hemoglobin A1c | percent | Change from Baseline at 6 Weeks | 
| blood insulin | nU/L | Change from Baseline at 6 Weeks | 
| systolic/diastolic blood pressures | mmHg | Change from Baseline at 6 Weeks | 
| blood lipids | mmol/L | Change from Baseline at 6 Weeks | 
| alanine aminotransferase and aspartate aminotransferase | U/L | Change from Baseline at 6 Weeks | 
| chest computed tomography scan | image | Change from Baseline at 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fast weight loss, COVID-19, Influenza, Non-Communicable Diseases (NCDs)