Effect of Weight Load on Bone Glucose Uptake in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in glucose uptake in loaded bones
研究概览
简要总结
Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the world. This trial may result in improved understanding of the causes of obesity and obesity-related disorders. Published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. Recently published data further show comparable results in humans when carrying an additional weight.
The investigators aim to confirm and further investigate these findings in humans. The investigators plan to let obese participants carry weight vests and monitor their change in glucose uptake in different tissues. This to further examine the effects increased axial loading has on glucose metabolism in different parts of the body.
详细描述
STUDY OBJECTIVES AND ENDPOINTS
Primary objective
- Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in bone more than sitting (no load) for 3 hours.
Secondary objectives 2. Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in fat tissue more than sitting (no load) for 3 hours. 3. Determine if standing with a heavy weight vest (high load, i.e. 11 percent of body weight) for 3 hours increase glucose uptake in muscle more than sitting (no load) for 3 hours.
STUDY DESIGN AND PROCEDURES
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent to participate in the study.
- •Consent out of free will.
- •18-65 years of age.
- •Maximum body weight of 115 kg.
- •Obesity as defined by a BMI >30 and ≤35 kg/m
- •Fat mass >25 percent of total body weight.
- •Willingness to comply with the study protocol.
- •Confirmation of adequate function of major organs and systems as judged by investigator
- •Normal or clinically non-significant screening of blood samples:
- •Hemoglobin (Hb), White Blood Cell Count (WBC), thrombocyte count, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), creatinine, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), glycated hemoglobin (HbA1c), fasting blood glucose, C-reactive protein (CRP), free thyroxine (fT4), thyroid stimulating hormone (TSH), Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL).
- •Normal or clinically non-significant aberrations of screening blood samples are defined as:
- •i. Normal: Values within the reference interval supplied by the Turku University Hospital lab.
- •ii. Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
排除标准
- •Chronic disease that could interfere with the participation in the study as judged by the investigator such as neurological, renal, hepatic, endocrine, cardiovascular, pulmonary, hematological, or gastrointestinal disorders.
- •Diagnosed diabetes.
- •Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip or knee pain.
- •Regular consumption of medications or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
- •a. β-blockers, Glucagon-Like Peptide 1 (GLP-1)-agonists, Dipeptidyl Peptidase-IV (DPP-IV)-inhibitors, Sodium-glucose Cotransporter-2 (SGLT2)-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, intra articular or parenteral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
- •Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
- •Reduced mobility as judged by the investigator.
- •Use of any illegal drugs according to local regulations, use of tobacco or nicotine products (e.g. cigarettes or snuff) or consuming excessive amounts of alcohol.
- •a. Excessive amounts of alcohol defined as:
- •i. Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 percent alcohol) or equivalent as judged by the investigator during an ordinary week will not be accepted.
- •Change in body weight of ≥5 kg during the last 3 months.
- •Drastic change in lifestyle during the last 3 months including a significant change in physical activity or dietary habits as judged by the investigator.
- •Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
结局指标
主要结局
Change in glucose uptake in loaded bones
时间窗: 3 hours
Change in ratio between glucose uptake in loaded bones (e.g. femur, tibia) and glucose uptake in not loaded bones (e.g. humerus). Change in ratio (in percent between high load and no load) compared after 3 hours of different interventions.
次要结局
- Change in glucose uptake in loaded fat tissues(3 hours)
- Change in glucose uptake in loaded muscles(3 hours)