Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial
- Conditions
- Clinical Trial
- Interventions
- Dietary Supplement: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
- Registration Number
- NCT05635539
- Lead Sponsor
- University Medical Center, Kazakhstan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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)
- patients with acute respiratory failure and assisted ventilation requirement
- respiratory rate ≥ 30 times per minute
- oxygen saturation ≤ 93% by finger oximetry at resting status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description patients with Influenza "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet 35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH patients with COVID "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet 27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH
- Primary Outcome Measures
Name Time Method Clinic and infectious tests for COVID and Influenza Change from Baseline at 6 Weeks 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.
C-reactive protein Change from Baseline at 6 Weeks mg/L
weight loss during 14 days Change from Baseline at 14 days kg
- Secondary Outcome Measures
Name Time Method glycosylated hemoglobin A1c Change from Baseline at 6 Weeks percent
systolic/diastolic blood pressures Change from Baseline at 6 Weeks mmHg
fasting blood glucose Change from Baseline at 6 Weeks mmol/L
blood insulin Change from Baseline at 6 Weeks nU/L
blood lipids Change from Baseline at 6 Weeks mmol/L
chest computed tomography scan Change from Baseline at 14 days image
alanine aminotransferase and aspartate aminotransferase Change from Baseline at 6 Weeks U/L
Trial Locations
- Locations (1)
Kuat Pernekulovich Oshakbayev
🇰🇿Astana, Kazakhstan