Clinical trial NCT05635539: Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial
Official title: A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Keywords: COVID-19
Influenza
Non-Communicable Diseases (NCDs)
fast weight loss
Lead sponsor: University Medical Center, Kazakhstan
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 27 patients with COVID and 35 patients with Influenza
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinic and infectious tests for COVID and Influenza
timeFrame: Change from Baseline at 6 Weeks
measure: weight loss during 14 days
timeFrame: Change from Baseline at 14 days
measure: C-reactive protein
timeFrame: Change from Baseline at 6 Weeks
Secondary outcomes:
measure: fasting blood glucose
timeFrame: Change from Baseline at 6 Weeks
measure: glycosylated hemoglobin A1c
timeFrame: Change from Baseline at 6 Weeks
measure: blood insulin
timeFrame: Change from Baseline at 6 Weeks
measure: systolic/diastolic blood pressures
timeFrame: Change from Baseline at 6 Weeks
measure: blood lipids
timeFrame: Change from Baseline at 6 Weeks
measure: alanine aminotransferase and aspartate aminotransferase
timeFrame: Change from Baseline at 6 Weeks
measure: chest computed tomography scan
timeFrame: Change from Baseline at 14 days
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Kuat Pernekulovich Oshakbayev
Study officials:
affiliation: University Medical Center
name: Alaty N Nabiyev, Dr.
role: STUDY_DIRECTOR
References: