A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Clinic and infectious tests for COVID and Influenza
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinic and infectious tests for COVID and Influenza
Time Frame: 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
Time Frame: Change from Baseline at 6 Weeks
mg/L
weight loss during 14 days
Time Frame: Change from Baseline at 14 days
kg
Secondary Outcomes
- glycosylated hemoglobin A1c(Change from Baseline at 6 Weeks)
- systolic/diastolic blood pressures(Change from Baseline at 6 Weeks)
- fasting blood glucose(Change from Baseline at 6 Weeks)
- blood insulin(Change from Baseline at 6 Weeks)
- blood lipids(Change from Baseline at 6 Weeks)
- chest computed tomography scan(Change from Baseline at 14 days)
- alanine aminotransferase and aspartate aminotransferase(Change from Baseline at 6 Weeks)
Investigators
Kuat Oshakbayev
a principal investigator
University Medical Center, Kazakhstan