Scalp Hair Metabolomics as a Novel Biomarker of Poor Metabolic Health in Individuals With Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amino acid concentration
研究概览
简要总结
The purpose of this research study is to investigate how body weight and weight-loss surgery affect the natural chemicals found in scalp hair over time. We will also find out how common and severe hair thinning/hair loss and muscle loss are in the first 6 months after bariatric surgery.
详细描述
The investigators will recruit 30 subjects with severe obesity scheduled for bariatric surgery and 30 healthy-weight controls.
Following written informed consent, the investigators will collect the study subject's medical information, conduct a dietary and quality-of-life survey, take body measurements, obtain scalp photos, perform a hair-pull test, collect a hair sample, and conduct muscle strength testing. Controls will be assessed only at baseline. Those with severe obesity will return at 4 ± 2 weeks, 12 ± 4 weeks, and 26 ± 4 weeks following bariatric surgery to repeat the study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •Age 21-70 years
- •Ability to provide informed consent
- •Healthy weight controls:
- •BMI of 18.5-24.9 kg/m2
- •No chronic disease
- •No long-term medications
- •Severe obesity:
- •BMI of > 32.5 kg/m2
- •Scheduled to undergo bariatric surgery
排除标准
- •Any factors likely to limit adherence to study protocol
- •Any history of autoimmune or scarring alopecia (eg. alopecia areata, discoid lupus, lichen planopilaris)
研究组 & 干预措施
Healthy controls
Healthy controls with normal weight
Severe obestiy
Participants with Severe obesity
结局指标
主要结局
Amino acid concentration
时间窗: From enrollment to the end of study duration at 6 months
Post-surgery changes in scalp hair amino acid concentration following bariatric surgery
次要结局
- Scalp hair amino acid concentration (between groups)(At the time of enrollment)
- Grip strength(From enrollment until the end of the study at 6 months)
- Sit to stand speed(From enrollment until study completion at 6 months)
- Severity of hair loss(From the time of enrolment until the end of the study at 6 months)
- Hair-specific Skindex-29 score(From enrollment until study completion at 6 months)