Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women: A Single-Group Pre-Post Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Lipid Profile
研究概览
简要总结
This study aims to evaluate the short-term effects of estrogen therapy on lipid metabolism and insulin sensitivity in hypogonadal women. Participants receiving estrogen therapy will be assessed before initiation of treatment and after the treatment period to determine changes in serum estrogen levels, fasting glucose, fasting insulin, and lipid profile. Insulin sensitivity will be assessed using the HOMA-IR index. The findings may contribute to a better understanding of the short-term metabolic effects of estrogen therapy in women with hypogonadism.
详细描述
Female hypogonadism is characterised by reduced ovarian function and estrogen deficiency and may be associated with metabolic alterations, including disturbances in lipid metabolism and insulin sensitivity. Estrogen therapy is used to restore estrogen levels in women with estrogen deficiency; however, the short-term metabolic effects of estrogen therapy in women with hypogonadism require further evaluation.
This single-group pre-post experimental study will evaluate changes in lipid metabolism and insulin sensitivity among hypogonadal women receiving oral estrogen therapy. Eligible participants will undergo baseline assessment before initiation of estrogen therapy and will be reassessed following the treatment period. Serum estrogen levels, fasting glucose, fasting insulin, and lipid profile, including total cholesterol, LDL-C, HDL-C, and triglycerides, will be measured at baseline and follow-up. Insulin sensitivity will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index.
The study will assess changes in these metabolic parameters following estrogen therapy and provide evidence regarding its short-term effects on lipid metabolism and glucose-insulin regulation in hypogonadal women. The findings may contribute to a better understanding of the metabolic response to estrogen therapy and inform future research on the management of metabolic risks associated with estrogen deficiency.
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
盲法说明
This is a single-arm, open-label, pre-post study. Participants, care providers, investigators, and outcomes assessors will not be masked.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 50 years.
- •Diagnosis of hypogonadism, including:
- •Primary ovarian insufficiency (POI)
- •Hypogonadotropic hypogonadism
- •Early menopause
排除标准
- •Contraindications to estrogen therapy, including a history of thromboembolic events or certain hormone-sensitive cancers.
- •Pre-existing conditions that may significantly affect lipid metabolism or insulin sensitivity.
- •Use of medications known to affect lipid metabolism or insulin sensitivity.
- •Pregnancy or lactation.
研究组 & 干预措施
Estrogen therapy
Participants with hypogonadism who have not previously started estrogen therapy will receive estrogen therapy as prescribed by their treating healthcare professional. Participants will undergo assessment at baseline before initiation of therapy and again after 3 months of treatment. Changes in lipid profile parameters (total cholesterol, LDL-C, HDL-C, and triglycerides) and insulin sensitivity, assessed using fasting glucose, fasting insulin, and HOMA-IR, will be evaluated between baseline and 3 months. Adverse events and treatment-related complications will also be recorded during the follow-up period.
干预措施: Estrogen (Drug)
结局指标
主要结局
Change in Lipid Profile
时间窗: Baseline to 3 Months
Change in total cholesterol, LDL-C, HDL-C, and triglyceride levels from baseline (before initiation of estrogen therapy) to 3 months after initiation of estrogen therapy.
Change in Insulin Sensitivity (HOMA-IR) from Baseline to 3 Months
时间窗: Baseline to 3 Months
Change in insulin resistance estimated using the HOMA-IR index from baseline (before initiation of estrogen therapy) to 3 months after initiation of estrogen therapy. HOMA-IR will be calculated from fasting glucose and fasting insulin measurements.
次要结局
- Change in a Serum Estrogen Level(Baseline to 3 Months)