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

Clinical Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635539
• Other study ID #: AP05135241
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2024
• Source: University Medical Center, Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Trial
• Weight Loss

Intervention

Dietary Supplement:
• "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
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.

Locations

Country	Name	City	State
Kazakhstan	Kuat Pernekulovich Oshakbayev	Astana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	weight loss during 14 days	kg	Change from Baseline at 14 days
Primary	C-reactive protein	mg/L	Change from Baseline at 6 Weeks
Secondary	fasting blood glucose	mmol/L	Change from Baseline at 6 Weeks
Secondary	glycosylated hemoglobin A1c	percent	Change from Baseline at 6 Weeks
Secondary	blood insulin	nU/L	Change from Baseline at 6 Weeks
Secondary	systolic/diastolic blood pressures	mmHg	Change from Baseline at 6 Weeks
Secondary	blood lipids	mmol/L	Change from Baseline at 6 Weeks
Secondary	alanine aminotransferase and aspartate aminotransferase	U/L	Change from Baseline at 6 Weeks
Secondary	chest computed tomography scan	image	Change from Baseline at 14 days