Exercise Training Study Before Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.
Researchers will compare the effects of walking before bariatric surgery on:
- Insulin sensitivity (diabetes risk factor)
- Health of blood vessels
- Rate of complications after surgery
- Weight
- Body Fat
- Fitness level
详细描述
The purpose of the present study is to evaluate the impact of 8 weeks of supervised aerobic exercise prior to bariatric surgery on insulin sensitivity using the hyperinsulinemic-euglycemic clamp. Participants will be recruited from the area surrounding the UVA hospital, while the primary outcome will be insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp procedure and secondary outcomes include the effects of the exercise intervention on surgical outcomes and cardiometabolic and arterial health in bariatric patients.
Objectives:
Primary Objective: To investigate the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery.
Secondary Objectives: To examine the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes, such as length of stay post-surgery, and other clinically relevant outcomes, such as cardiometabolic and arterial health, in adults following bariatric surgery.
Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 35 - 45 kg/m
- •For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study.
- •Considered sedentary based on self-reported inactivity of < 2-3 x/week of MVPA within previous 3 months before enrollment.
- •Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes.
- •Surgery approved within 6-9 months of initial visit.
- •Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate.
- •Willingness to accept group randomization assignment.
排除标准
- •Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease.
- •Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis.
- •HIV or tuberculosis.
- •Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc).
- •Resting SBP > 150 mmHg, DBP > 100 mmHg.
- •Current pregnancy or plans to become pregnant during intervention.
- •Plans to be away from the Charlottesville, VA area for > 1 week during intervention or plans of relocating during the intervention.
- •Any medical or health condition (e.g., musculoskeletal, orthopedic, or neurological conditions) that is contraindicated for safe exercise testing and training.
- •Previous weight-loss surgeries or revisions
研究组 & 干预措施
Exercise Group (EX-group)
The EX-group will complete 8 weeks of supervised aerobic exercise training. The EX-group will also continue normal care with bariatric doctors and nurses along with the exercise intervention.
干预措施: Exercise Group (Other)
Standard Care Only Group (SC-group)
The SC-group will only complete the orientation visit and testing visits. The participants that are randomized to this group will continue normal care with bariatric doctors and nurses. They will participate in study assessment visits only.
结局指标
主要结局
Insulin sensitivity
时间窗: Change from baseline to after surgery (12 weeks)
Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp
次要结局
- Lean body mass(Change from baseline to after surgery (12 weeks))
- Hemoglobin A1c(up to 12 weeks)
- Surgical outcomes - emergency department visits(Change from baseline to after surgery (12 weeks))
- Surgical outcomes - time of surgery(Intraoperative)
- Body fat(Change from baseline to after surgery (12 weeks))
- Bone mineral density(Change from baseline to after surgery (12 weeks))
- Surgical outcomes - readmission within 30 days of surgery(within 30 days)
- Surgical outcomes - IV treatment as an outpatient(Change from baseline to after surgery (12 weeks))
- Surgical outcomes - length of stay after surgery completion(Change from baseline to after surgery (12 weeks))
- Flow-mediated dilation (FMD)(Change from baseline to after surgery (12 weeks))
- Blood Lipids(Change from baseline to after surgery (12 weeks))
- Plasma insulin(Change from baseline to after surgery (12 weeks))
- Cardiorespiratory fitness(Change from baseline to after surgery (12 weeks))
- Pulse-wave analysis (PWA)(Change from baseline to after surgery (12 weeks))
- Pulse-wave velocity (PWV)(Change from baseline to after surgery (12 weeks))
- Visceral adiposity(Change from baseline to after surgery (12 weeks))
- Weight(Change from baseline to after surgery (12 weeks))
- Plasma glucose(Change from baseline to after surgery (12 weeks))
- Quality of life (SF-36)(Change from baseline to after surgery (12 weeks))
研究者
Damon Swift
Associate Professor
University of Virginia