Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effects of Chronic estrogen therapy on insulin secretion
研究概览
简要总结
The study will test:
- whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
- whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
- whether estrogen therapy leads to enhanced immune response in older transwormen
详细描述
All subjects will participate in a 2-hour oral glucose tolerance test (OGTT) and DXA scan for estimation of lean body mass. Only the transgender subjects will have a repeat OGTT two weeks after discontinuation of Gender Affirming Hormone Therapy (GAHT).
Beta cell function will be correlated with the Estrogen/Testosterone ratio to evaluate the relationship between sex hormones and beta cell function. Plasma Glucagon-like peptide 1 (GLP-1) response during the OGTT will be measured to evaluate if estrogen treatment modulates insulin secretion by increasing GLP-1 secretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy volunteers: healthy male or female
- •MTF transgender
- •FTM transgender
- •Non-diabetic (A1c<6.5%), fasting glucose <126mg/dl and OGTT after 2 hr <200mg/dl)
- •Stable hormone treatment (estrogen or testosterone) for at least 6 months
排除标准
- •History of or newly diagnosed diabetes mellitus
- •For healthy volunteers, not current treatment with estrogen or testosterone
- •For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA)
- •For MTF and FTM transgender, less than 6 months of stable hormone treatment
- •Anemia with hemoglobin (Hb) <11.0 hematocrit (Hto) < 34 and Glomerular Filtration rate (GFR) <30
研究组 & 干预措施
Healthy Volunteer Male
Healthy male currently on no testosterone treatment
干预措施: Botnia Clamp (Drug)
Healthy Volunteer Female
Healthy female currently on no estrogen treatment
干预措施: Botnia Clamp (Drug)
MTF group
MTF transgender currently on estrogen treatment
干预措施: Botnia Clamp (Drug)
MTF group
MTF transgender currently on estrogen treatment
干预措施: Withdrawal of Gender Affirming Hormone Therapy (GAHT) (Other)
FTM group
FTM transgender group currently on testosterone treatment
干预措施: Botnia Clamp (Drug)
FTM group
FTM transgender group currently on testosterone treatment
干预措施: Withdrawal of Gender Affirming Hormone Therapy (GAHT) (Other)
结局指标
主要结局
Effects of Chronic estrogen therapy on insulin secretion
时间窗: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic testosterone therapy on insulin secretion
时间窗: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic estrogen therapy on insulin sensitivity
时间窗: Baseline to 6 months
Change in beta cell function
Effects of Chronic testosterone therapy on insulin sensitivity
时间窗: Baseline to 6 months
Change in beta cell function
次要结局
- Immune response change(Baseline to 6 months)