Effects of GLP-1 RAs on Human Lactation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Hourly milk production rate
研究概览
简要总结
There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk.
The main questions the study will address are:
- Does GLP-1 RA-induced weight loss increase or decrease breastmilk production?
- Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content?
Researchers will assess milk production rates before and after mothers begin taking injected GLP-1 RA medications to decrease their body weight. Weight loss will be confirmed with 7-day body weight averages.
Participants will:
- Weigh themselves and report measurements daily.
- Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each).
During each visit, participants will:
- Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production.
- Provide 1-3 oz of milk for further study.
- Answer questions about breastfeeding patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breastfeeding mothers of single or multiple infants.
- •Milk removal at least 4x daily
- •Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)
- •Access to a breastpump, if needed for maintaining breastfeeding behaviors.
- •Willingness to provide 1-3 oz of breastmilk per study visit.
- •Willingness to track and report body weight daily.
- •Willingness to maintain breastfeeding behaviors for the duration of the study.
排除标准
- •Currently taking GLP-1 RA medication or other weight loss medication
- •Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.
结局指标
主要结局
Hourly milk production rate
时间窗: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.
Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.
Milk macronutrient composition
时间窗: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.
Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.
次要结局
未报告次要终点