Santé, Imagerie et Cognition à Travers la Transition ménopausique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- cerebral metabolic rates (μmol/100 g/min) measured by PET (11C-AcAc +18F-FDG)
研究概览
简要总结
This observational cross-sectional study aims to better understand how the menopausal transition affects brain energy metabolism and cognition. Menopause, a natural stage in a woman's life, is typically divided into three phases: premenopause, perimenopause, and postmenopause. This transition involves hormonal fluctuations and a decline in estrogen levels, which can impact physical, emotional, and cognitive well-being. Common symptoms include hot flashes, sleep disturbances, mood changes, and difficulties with memory and concentration.
Emerging evidence suggests that the decline in estrogen may impair how the brain uses glucose, its primary energy source. This reduction in glucose metabolism is thought to contribute to cognitive difficulties reported during midlife. In contrast, the brain's capacity to use ketones-alternative energy substrates produced during fasting or low-carbohydrate intake-appears preserved during aging and hormonal changes. Increasing circulating ketones may offer a promising strategy to support brain energy and cognitive function.
To explore these relationships, the study will employ advanced brain imaging (PET scans) to assess glucose and ketone uptake in the brain. Additional measures will include hormone levels, cognitive testing, continuous glucose monitoring, and MRI. PET tracers will also be used to evaluate estrogen receptor distribution, providing insight into how the brain responds to hormonal changes.
A total of 45 women aged 35-60 will be enrolled and categorized into three groups (15 per group): premenopause, perimenopause, and postmenopause. Each participant will attend four study visits that include questionnaires, blood tests, cognitive assessments, metabolic measurements, and imaging procedures.
The results may help identify early neurobiological and metabolic markers associated with the menopausal transition. These findings could inform new approaches to preserve brain health and prevent cognitive decline in aging women. Improving understanding of how the female brain adapts to hormonal shifts may ultimately support more targeted strategies for promoting healthy aging.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to read and speak French
- •Capable of understanding and signing informed consent GROUP SPECIFIC INCLUSION CRITERIA Premenopause: • Women aged 35 to 55; No change in menstrual cycle regularity over the past 10 months (variation less than 7 days per cycle)
- •Perimenopause: Women aged 40 to 60; Menstrual cycles varying by more than 7 days per cycle for at least 10 cycles, or no period for 3 to 11 months
- •postmenopause: Women aged 45 to 65; No menstrual period for ≥ 12 months
排除标准
- •Pregnancy, childbirth within the past 12 months, or breastfeeding
- •Use of hormone replacement therapy or hormonal contraceptives in the past 6 months
- •contraindications to MRI (e.g., presence of non-compatible metallic objects)
- •Claustrophobia
- •Type 1 diabetes
- •Adherence to a ketogenic intervention (e.g., ketone supplements, intermittent fasting, ketogenic diet) in the past 3 months
- •Engaging in intense physical activity 5 times per week or more
- •Any significant neurological disorder (e.g., dementia, brain tumor, seizure disorder, history of significant head trauma with persistent neurological deficits, known structural brain abnormalities)
- •History of oophorectomy or hysterectomy
- •Any significant psychiatric disorder (e.g., major depression within the past 2 years, bipolar disorder, schizophrenia)
- •Systemic diseases or unstable/uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes, kidney or liver disorders)
- •Any other condition that may interfere with participation, as judged by the study physician
结局指标
主要结局
cerebral metabolic rates (μmol/100 g/min) measured by PET (11C-AcAc +18F-FDG)
时间窗: 1 day at baseline
Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST).Total Cerebral metabolic rates (μmol/100 g/min) (CMR tot= CMR acac + CMRglu)
Tracer influx rates (k) measured by PET (11C-AcAc +18F-FDG)
时间窗: 1 day at baseline
Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST). tracer influx rates (K values).
次要结局
- distribution volume ratio of the estrogen receptor in the brain (by 18F-4FMFES PET)(1 day at baseline)
- Time-activity curves of the estrogen receptor in the brain (by 18F-4FMFES PET)(1 day at baseline)
- Glucose variability (SD of glucose measured by continuous glucose monitoring)(Over 5 days following sensor placement et stabilisation)
- Glucose average (mean of glucose measured by continuous glucose monitoring)(Over 5 days following sensor placement et stabilisation)
- Time in range(Over 5 days following sensor placement et stabilisation)