NCT04754581招募中不适用
Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes
AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Individual steps of muscle glucose uptake (pre-exercise)
研究概览
简要总结
The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-65 years
- •Men and women
- •Body mass index (BMI) between 25 and 45 kg/m2
- •Sedentary (1 day or less per week of structured exercise)
- •Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
- •Weight stable (± 2 kg) for prior 3 months
- •Willing to commit to the schedule of assessment visits, including the exercise intervention
排除标准
- •Currently taking insulin, injectable incretin mimetics and thiazolidinediones
- •Taking more than two glucose-lowering medications
- •Resting blood pressure ≥ 160/100 mm Hg
- •Triglycerides ≥ 500 mg/dL
- •Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise training protocol
- •Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
- •Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise training
- •Pulse check ("Allen test") indicates participant has poor blood flow in the hands
- •Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)
- •Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year
- •Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- •Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- •Participant is currently taking anti-inflammatory medication or has had inflammatory medication within 1 week prior to screening (including over the counter formulations: e.g. Aleve, Motrin, Ibuprofen, Naproxen, low dose ASA.
- •New onset (<3 months on a stable regime) hormone replacement therapy
- •Current use of beta-adrenergic blocking agents
- •Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- •Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- •Abnormal blood count/anemia, blood transfusion or blood donation within the last 2 months
- •Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)
- •Current drug or alcohol abuse/dependence
- •Metal implants (pace-maker, aneurysm clips) based on investigator's judgment at screening
- •Not physically capable of performing the exercise required of the study protocols
- •Plans to be away >2 weeks in the next 3 months
- •Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.
- •Unable to tolerate MRI or claustrophobia.
- •Nickel allergy
- •Lidocaine allergy
- •Unable or unwilling to communicate with staff or to provide written informed consent
结局指标
主要结局
Individual steps of muscle glucose uptake (pre-exercise)
时间窗: 24 hours
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
Individual steps of muscle glucose uptake (post-exercise)
时间窗: 24 hours
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
次要结局
未报告次要终点
研究者
研究点 (2)
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