A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clinic and infectious tests for COVID and Influenza
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •patients with acute respiratory failure and assisted ventilation requirement
- •respiratory rate ≥ 30 times per minute
- •oxygen saturation ≤ 93% by finger oximetry at resting status
研究组 & 干预措施
patients with COVID
27 patients with COVID in comorbidity with NCDs as T2D, hypertension, and NASH
干预措施: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet (Dietary Supplement)
patients with Influenza
35 patients with Influenza in comorbidity with NCDs as T2D, hypertension, and NASH
干预措施: "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet (Dietary Supplement)
结局指标
主要结局
Clinic and infectious tests for COVID and Influenza
时间窗: 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
时间窗: Change from Baseline at 6 Weeks
mg/L
weight loss during 14 days
时间窗: Change from Baseline at 14 days
kg
次要结局
- glycosylated hemoglobin A1c(Change from Baseline at 6 Weeks)
- alanine aminotransferase and aspartate aminotransferase(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)
- systolic/diastolic blood pressures(Change from Baseline at 6 Weeks)
研究者
Kuat Oshakbayev
a principal investigator
University Medical Center, Kazakhstan