NCT01911091进行中（未招募）不适用
Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue
AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Measure change in mitochondrial capacity
研究概览
简要总结
The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.
详细描述
Study Objectives:
- To identify specific changes in messenger ribonucleic acid (mRNA)/micro ribonucleic acid (miRNA) expression in muscle associated with higher or lower relative measures of mitochondrial capacity and fat oxidation.
- To identify secreted factors/miRNAs that specifically relate to the metabolic response of muscle and that are present after a single initial bout of exercise.
- To collect the appropriate clinical samples (muscle and adipose tissue, plasma/serum) to enable validation of myokines associated with changes in oxygen consumption/mitochondrial content via in vivo and in vitro discovery efforts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Applicable to all Groups
- •Healthy men and women, aged 18 - 40, inclusive.
- •Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw
- •Applicable to Group 1
- •BMI between 22 and 29.9 kg/m2
- •Not involved in regular exercise program
- •Willing to exercise every day for the study period
- •Applicable to Group 2
- •BMI between 22 and 29.9 kg/m2
- •Maximal oxygen uptake (VO2max) ≥ 45 ml/kg fat-free mass
- •Engaged in a minimum of 1.5 h of moderate to vigorous intensity aerobic exercise 3 times/ week
- •Applicable to Group 3
- •BMI ≥ 30 kg/m2 and weight ≤ 350 lbs
- •Not involved in a regular exercise program
排除标准
- •Applicable to All Groups
- •History of Type 2 Diabetes
- •"Unfavorable anatomy" for continuous venous blood sample collection
- •Abnormal resting ECG
- •Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp < 140/90 on medications)
- •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
- •New onset (<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy
- •Alcohol or other drug abuse
- •Smoking within the past 3 months
- •Females that are currently or have been pregnant or are currently or have nursed a child within the last 12 months (minimum).
- •Parental enrollment into the study that compromises the well being of the child [no partner or connected caregiver]
- •Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements
- •Increased liver function tests
- •Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc
- •Any New York Heart Association class of congestive heart failure
- •History of deep vein thrombosis or pulmonary embolism
- •Significant varicose veins
- •Abnormal blood count/Anemia, or blood donation within the last 2 months
- •Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- •Bariatric surgery or liposuction within the previous 3 years
- •Cancer (active malignancy with or without concurrent chemotherapy)
- •Rheumatoid disease
- •Bypass graft in limb
- •Known genetic factor (Factor V Leiden, etc) or hypercoagulable state
- •Diagnosed peripheral arterial or vascular disease, or intermittent claudication
- •Family history of primary deep vein thrombosis or pulmonary embolism
- •Peripheral neuropathy
- •Claustrophobia
- •Frequent nocturnal urination and/or sleep apnea
- •Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participants' ability to complete the training protocol
- •Applicable to Group 2
- •Gait problems
- •Major Depression
- •Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion
- •Unwilling or unable to complete the protocol
- •Applicable to Group 3
- •HbA1c ≥ 6.5% (O)
结局指标
主要结局
Measure change in mitochondrial capacity
时间窗: Baseline (Day -6), Day 18
The difference will be measured in obese, lean and athletic participants. The Phosphocreatine (PCr) recovery time constant and the PCr level in oxygenated muscle at rest will be used to calculate maximum mitochondrial capacity.
次要结局
- Measure change of expression of proteins(Baseline (Day -6), Day 0, Day 5, Day 12, Day 18)
- Measure change in mRNA/miRNA levels(Baseline (Day -6), Day 0, Day 5, Day 12, Day 18)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Developing Allogeneic Musculoskeletal TherapiesOsteoarthritisNCT06167928Keele University325
已完成
不适用
A Pilot Study of Biomarkers for Spinal Muscular AtrophySpinal Muscular AtrophyNCT00756821Carelon Research130
已完成
不适用
Alterations in Muscle After Total Knee ArthroplastyKnee OsteoarthritisNCT02281877University of Colorado, Denver20
招募中
不适用
Identification and Characterization of Novel Proteins and Genes in Head and Neck CancerHead and Neck CancerNCT00230308Stanford University500
尚未招募
不适用
Establishment of a CSF Bank for the Development of Biomarkers of Smooth Muscle Cell (SMC) Damage in Monogenic Cerebral Small Vessel DiseaseCerebral Small Vessel DiseasesCADASIL (Diagnosis)NCT05793424Assistance Publique - Hôpitaux de Paris90