The Effects of a GLP-1R Agonist (the Drug Wegovy®) on Body Composition and Performance in Military Personnel
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
The obesity epidemic presents a growing concern in the United States, affecting more than 42% of adults. This epidemic extends its impact to chronic diseases and escalating healthcare expenses. Its reach has even influenced the military, with more than 20% of Soldiers being classified as obese, based on Body Mass Index ≥30 kg/m2. Current preventative and countermeasures have produced limited success, prompting consideration of pharmacotherapy. Within this context, glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, have emerged as a promising treatment for obesity. Semaglutide can induce significant weight loss, primarily through fat reduction. However, questions persist regarding its effects on lean mass, physical performance, bone structure, and how it influences the underlying metabolic and hormonal milieu. Furthermore, no studies have been completed in military personnel, who must exercise regularly. Therefore, the investigators will conduct a single-center, open-label, observational trial. The trial will consist of a 24-week semaglutide treatment period and a non-treated 52-week follow-up period. We will test the feasibility and potential benefits of semaglutide in military populations, with a focus on understanding how semaglutide influences body composition, physical performance, hormones, and metabolism. This research holds military significance as obesity rates among service members continue to rise, undermining their medical readiness. Ultimately, it is important to understand if GLP-1RAs can provide a viable solution to obesity in military personnel and if there might be an unexpected effect on physical readiness due to the nature of the weight loss. This could cut down on healthcare expenses by reducing the reliance on weight-related initiatives and, consequently, lowering military separations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active-duty military personnel
- •Age ≥ 18 years at the time of signing informed consent.
- •Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, etc.)
- •History of at least one self-reported effort to lose body weight.
- •Ability to exercise ≥ 3x per week during the study.
排除标准
- •Currently in Basic Combat Training, Advanced Individual Training, or One Station Unit Training, or equivalence in other military services.
- •Current or history of Type 1 or Type 2 Diabetes, cardiovascular (e.g., heart disease, peripheral artery disease), musculoskeletal (e.g., myopathies), immune (e.g., lupus, asthma), gastrointestinal (e.g., irritable bowel syndrome, pancreatitis), neurological (e.g., dystonia), pulmonary (pulmonary fibrosis, COPD, lung cancer), or renal diseases (e.g., kidney diseases), and eating disorders (e.g., bulimia nervosa, anorexia nervosa).
- •History of cholecystectomy
- •Personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia type
- •Participants who are pregnant or breastfeeding, or those who may be pregnant or were pregnant in the last 12 months.
- •Male and female participants who plan or will attempt to become pregnant or help conceive a child within two months of treatment.
- •Inability to exercise ≥ 3x per week during the study.
- •Currently taking or history of routine use of medications known to affect metabolism or performance (e.g., thiazide diuretics, oral steroids, testosterone replacement therapy, etc.).
- •Self-reported change in body weight ≥ 5 kg within 90 days before screening.
- •Treatment with any medication for the indication of obesity within 90 days before screening.
- •Treatment with other orally administered medications such as sulfonylureas, sitagliptin, phenytoin, levothyroxine, albuterol, prednisone, and other drugs as identified during screening by the medical screening and staff.
- •Current or previously suspected alcohol abuse (defined as Harmful Use by the World Health Organization), those who meet criteria for alcohol abuse disorder (as outlined in the DSM-5), or other substance abuse (i.e., the use of illegal drugs or the use of prescription or over-the-counter drugs for purposes other than those for which they are meant to be used, or in excessive amounts.
- •History of major depressive disorder.
- •Participants with implanted or external electrical devices (e.g., pacemakers).
- •On a specialized diet (e.g., keto, intermittent fasting).
- •Claustrophobia or difficulty breathing with a face mask.
- •Known or suspected hypersensitivity to study product(s) or related products.
研究组 & 干预措施
Semaglutide Treatment
Semaglutide will be self-administered by participants with a prefilled pen injector on the same day each week, at any time of day, with or without meals. It will be initiated at a dose of 0.25 mg once weekly for the first 4 weeks, with the dose increased every 4 weeks to reach a maintenance dose of 2.4 mg weekly by week 16. They will remain on the maintenance dosage of 2.4mg until week 24. If participants cannot reach 2.4 mg/week they will stop at the maximal tolerable dose (e.g., 1.7 mg/week).
After 24-weeks, treatment will be stopped, and participants will remain in the trial for 1 year with follow-up assessments at week 48 and week 76.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Body composition
时间窗: 24 weeks
the percentage of lean and fat mass loss during semaglutide treatment.
Physical Performance
时间窗: 24 weeks
the percent change in VO2peak (mL/kg/min) during semaglutide treatment.
Weight Loss
时间窗: 24 weeks
the amount of body weight loss in kilograms caused by semaglutide in 24 weeks.
次要结局
- Weight Loss Maintenance(76 weeks)
- Eating habits and mediators of eating behavior(76 weeks)
研究者
Brandon Roberts
Principal Investigator
United States Army Research Institute of Environmental Medicine