The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity.
The main questions it will answer includes:
- Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone
- Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life
Participants will:
- Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician
- (Exercise group only) Will perform exercise ~3 times a week at the University of Virginia). Walking on a treadmill and resistance training
- Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures
详细描述
The new type class of weight loss medications called GLP-1 medications have been shown to cause weight loss and improve risk factors for heart disease and diabetes. One thing that is currently unknown is whether exercise augments the impact of weight loss in people taking GLP-1 medication. The EXER-MED study is a pilot study evaluating the effect of 16 weeks of exercise training with GLP-1 medication compared to taking the medication alone. We will evaluate the impact of the study groups on weight, body composition (percent fat, percent lean mass), blood pressure, arterial stiffness, blood work (cholesterol, blood pressure, glucose, insulin) and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Men and women 30-65 years of age, postmenopausal women included
- •27-29.9 with an additional CVD risk factor or 30-40 kg/m2
- •For overweight adults only: additional cardiometabolic risk factor (diagnosed dyslipidemia, hypertension)
- •Willingness and adequate health to go on weight loss medication
- •The capability and willingness to provide written informed consent
- •Approval of their primary care provider to go on weight loss medication
排除标准
- •Including but not limited to serious arrhythmias
- •Cardiomyopathy
- •Congestive heart failure
- •Stroke or transient ischemic attacks
- •Peripheral vascular disease
- •Previous history of myocardial infarction or stroke
- •Previous diagnosis or taking medication for type 1 or 2 diabetes, fasting glucose >125 mg/dL or HbA1C ≥6.5%
- •Systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg.
- •Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
- •Conditions that can be aggravated or are contraindicated by exercise training
- •Plans to be out of town more than 3 weeks in the next 4 months.
- •Currently pregnant or plans to become pregnant
- •Currently in a diet or exercise program
- •Non-compliance during screening or extreme difficulty in obtaining baseline blood samples
- •Enrolled in a different exercise program
- •Previous weight loss surgery
- •Use of weight loss medication within the last year
- •hypo/hyper thyroid (medicated or unmedicated)
研究组 & 干预措施
Exercise
Participants will perform aerobic and resistance exercise while taking monthly tirzepatide for 16 weeks
干预措施: Tirzepatide (Drug)
Exercise
Participants will perform aerobic and resistance exercise while taking monthly tirzepatide for 16 weeks
干预措施: Exercise (Behavioral)
Standard Care
Participants will take monthly Tirzepatide under the care of their primary care provider for 16 weeks
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Weight
时间窗: Baseline and 16 Weeks
Measurement will be taken 3 times and measured in kg. A positive value indicates an increase in weight and a negative value indicates a reduction in weight
次要结局
- Change in Waist Circumference(Baseline to Week 16)
- Change in Body Composition (Fat mass or Lean Mass)(Baseline to Week 16)
- Physical activity level(Baseline and 16 weeks)
- Changes in Blood Lipids Concentrations(Baseline to 16 weeks)
- Resting Metabolic Rate(Baseline and 16 Weeks)
- Change in Fasting Glucose Level(Baseline to 16 Weeks)
- Change in Fasting Insulin Level(Baseline to 16 Weeks)
- Change in Augmentation Index(Baseline to 16 Weeks)
- Changes in Blood Pressure (mmHg)(Baseline to 16 weeks)
- Change in hemoglobin A1C(Baseline and Week 16)
- Change in Cardiorespiratory Fitness(Baseline and 16 Weeks)
- Change in dietary quality(Baseline to Week 16)
- Quality of Life (IWQL-Lite)(Baseline to Week 16)
- Change in isokinetic dynamometry(Baseline and Week 16)
研究者
Damon Swift
Associate Professor
University of Virginia