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Completed

NCT Number: NCT05635539

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

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.

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Key information

Conditions

Clinical Trial COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Influenza, Human Lung Diseases Nidovirales Infections Noncommunicable Diseases Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuat Pernekulovich Oshakbayev

Astana, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet

Dietary Supplement

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.

Other names: very-low-calorie-diet

Primary outcomes

  1. 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.

  2. weight loss during 14 days

    Time frame: Change from Baseline at 14 days

    kg

  3. C-reactive protein

    Time frame: Change from Baseline at 6 Weeks

    mg/L

Secondary outcomes

  1. fasting blood glucose

    Time frame: Change from Baseline at 6 Weeks

    mmol/L

  2. glycosylated hemoglobin A1c

    Time frame: Change from Baseline at 6 Weeks

    percent

  3. blood insulin

    Time frame: Change from Baseline at 6 Weeks

    nU/L

  4. systolic/diastolic blood pressures

    Time frame: Change from Baseline at 6 Weeks

    mmHg

  5. blood lipids

    Time frame: Change from Baseline at 6 Weeks

    mmol/L

  6. alanine aminotransferase and aspartate aminotransferase

    Time frame: Change from Baseline at 6 Weeks

    U/L

  7. chest computed tomography scan

    Time frame: Change from Baseline at 14 days

    image

Sponsors and collaborators

Lead sponsor

University Medical Center, Kazakhstan

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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