Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients With Prediabetes

Обзор

This study is a single-arm, self-control, single-center study to investigate the molecular mechanism under exercise improving metabolism of patients with prediabetes. 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 clinical phenotypes such as body weight, body fat, laboratory values, and resting energy expenditure before and after exercise 2) the changes of peripheral blood mononuclear cell by single cell sequencing 3) search for potential biomarkers of exercise in improving metabolism through multi-omics integrated analysis of single-cell transcriptome, phenomics, metabolomics, 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 peripheral blood CD45+ cells detected by single cell sequencing [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

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06633575 · B2024-293R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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