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

Primary Purpose

Clinical Trial

Status
Completed
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
"Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
Sponsored by
University Medical Center, Kazakhstan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Trial focused on measuring COVID-19, Influenza, Non-Communicable Diseases (NCDs), fast weight loss

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuat Pernekulovich Oshakbayev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients with COVID

patients with Influenza

Arm Description

27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH

35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH

Outcomes

Primary Outcome Measures

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.
weight loss during 14 days
kg
C-reactive protein
mg/L

Secondary Outcome Measures

fasting blood glucose
mmol/L
glycosylated hemoglobin A1c
percent
blood insulin
nU/L
systolic/diastolic blood pressures
mmHg
blood lipids
mmol/L
alanine aminotransferase and aspartate aminotransferase
U/L
chest computed tomography scan
image

Full Information

First Posted
November 30, 2022
Last Updated
December 1, 2022
Sponsor
University Medical Center, Kazakhstan
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1. Study Identification

Unique Protocol Identification Number
NCT05635539
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center, Kazakhstan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Trial
Keywords
COVID-19, Influenza, Non-Communicable Diseases (NCDs), fast weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
27 patients with COVID and 35 patients with Influenza
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with COVID
Arm Type
Experimental
Arm Description
27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH
Arm Title
patients with Influenza
Arm Type
Experimental
Arm Description
35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH
Intervention Type
Dietary Supplement
Intervention Name(s)
"Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
Other Intervention Name(s)
very-low-calorie-diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinic and infectious tests for COVID and Influenza
Description
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.
Time Frame
Change from Baseline at 6 Weeks
Title
weight loss during 14 days
Description
kg
Time Frame
Change from Baseline at 14 days
Title
C-reactive protein
Description
mg/L
Time Frame
Change from Baseline at 6 Weeks
Secondary Outcome Measure Information:
Title
fasting blood glucose
Description
mmol/L
Time Frame
Change from Baseline at 6 Weeks
Title
glycosylated hemoglobin A1c
Description
percent
Time Frame
Change from Baseline at 6 Weeks
Title
blood insulin
Description
nU/L
Time Frame
Change from Baseline at 6 Weeks
Title
systolic/diastolic blood pressures
Description
mmHg
Time Frame
Change from Baseline at 6 Weeks
Title
blood lipids
Description
mmol/L
Time Frame
Change from Baseline at 6 Weeks
Title
alanine aminotransferase and aspartate aminotransferase
Description
U/L
Time Frame
Change from Baseline at 6 Weeks
Title
chest computed tomography scan
Description
image
Time Frame
Change from Baseline at 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaty N Nabiyev, Dr.
Organizational Affiliation
University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Kuat Pernekulovich Oshakbayev
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will make data available to any investigator/reviewer on their own request, so that the personal privacy of our patients cannot be compromised.

Learn more about this trial

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

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