Mechanism Study of Metabolic Response and Health Benefit Induced by Exercise

Обзор

This study is a single-arm, self-control, single-center study to investigate the mechanism under exercise inducing metabolic response and health benefit. 40 overweight/obese patients with prediabetes will be recruited in this study and instructed to participate in an 8-week exercise program. We aim to investigate 1) the changes of phenotypes such as body weight, body fat, laboratory values, appetite, resting energy expenditure, myokine-adipokine before and after exercise 2) the changes of serum metabolomics 3) search for potential biomarkers of exercise through multi-omics integrated analysis of metabolomics, metagenomics, phenomics, single-cell transcriptome, etc.

Вмешательства

• Поведенческое exercise intervention
  Patients will participate in an 8-week supervised aerobic exercise program, the intensity was set at the moderate to vigorous intensity (≥150mins/week exercise on the treadmill).

Первичные конечные точки

• Changes of serum metabolites detected by metabolomic profiling [Срок оценки: From enrollment to the end of exercise intervention at 8 weeks]

Вторичные конечные точки (2)

• Changes of anthropometrics including body weight, body fat, waist-to-hip ratio [Срок оценки: From enrollment to the end of exercise intervention at 8 weeks]
• Changes of laboratory values including plasma glucose, insulin, lipids, liver enzymes, thyroid hormones, inflammation cytokines [Срок оценки: From enrollment to the end of exercise intervention at 8 weeks]

Критерии участия

Критерии включения

• Han Chinese
• 5.6 mmol/L≤fasting blood glucose<7 mmol/L, and/or 7.8 mmol/L≤2h-postload glucose<11.1mmol/L, and/or 5.7% ≤HbA1c<6.5% without anti-hyperglycemic medicine treatment
• Voluntary participation and provide informed consent

Критерии исключения

• Participated in any clinical study in relation to weight-loss in the past 1 year
• Had a weight change of more than 10% present weight in the past 1 year
• Had a drug usage not suitable for this study in the past 3 months, such as hormone drug, orlistat, metformin, GLP-1 receptor agonists, lipid-lowering agents, liver protection drug, etc
• Presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, Cushing syndrome, etc
• Poorly controlled blood pressure: systolic blood pressure≥180mmHg, and/or diastolic blood pressure≥100mmHg
• Presence of serious heart, liver, kidney or systemic diseases
• Presence of skeletal and muscular diseases which make it difficult to exercise
• Received any kind of surgery in the past 1 year
• COVID-19 positive or recovery from COVID-19 within 4 weeks
• Presence of eating disorders or have a history of eating disorders
• Presence of sleep disorders
• Work in disrupted circadian rhythms
• Pregnancy and breastfeeding women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06633653 · FE22223R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗