The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain
研究概览
简要总结
The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.
详细描述
Epidemiological studies suggest there may be an interaction between type 2 diabetes and estrogen in postmenopausal women, such that diabetes may interact with estrogen levels over time to increase risk for dementia. The mechanism for this effect is now known. However, animal research suggests that it may occur through estrogen's effects on cellular metabolism of glucose and ketone bodies. The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing to provide written informed consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, postmenopausal, aged 60-80
- •Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
- •BMI 20-35 kg/m2
- •No evidence of dementia or mild cognitive impairment (MoCA score >25)
- •Able to access reliable transportation to study and intervention visits
排除标准
- •Use of hormone replacement therapy within the past 3 months
- •History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
- •Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
- •Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
- •Involved in another research study
- •Contraindications for MRI or PET scanning
- •Current smoker
研究组 & 干预措施
Post menopausal women with diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
干预措施: Estradiol patch (Drug)
Post menopausal women without diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
干预措施: Estradiol patch (Drug)
结局指标
主要结局
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain
时间窗: Baseline
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG will be quantified.
Acetoacetate Uptake (AcAc) PET--Whole Brain
时间窗: Baseline
Brain metabolism will be measured using PET tracers to examine brain ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of AcAc tracers will be quantified.
AcAc PET--Whole Brain
时间窗: Week 8
Brain metabolism will be measured using PET tracers to examine brain ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of AcAc tracers will be quantified.
FDG PET--Whole Brain
时间窗: Week 8
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG will be quantified.
Change in Uptake of Glucose and Ketone Bodies in Whole Brain and Alzheimer's Disease-related Regions of Interest.
时间窗: Baseline and 8 weeks
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET) and ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG and AcAc tracers will be quantified, as well as uptake of AcAc relative to FDG to find potential regions of compensatory ketone use
次要结局
- Executive Function Composite Score(Baseline and Week 8)
- California Verbal Learning Task (CVLT) Long Delay Free Recall(Baseline and Week 8)
- Benton Visual Retention Task (BVRT) Total Score(Baseline and Week 8)
- Prospective Memory(Baseline and Week 8)
- Verbal Fluency (Letters)(Baseline and Week 8)
- Verbal Fluency Score (Fruits and Vegetables)(Baseline and Week 8)
- Digit Span Forward Total Correct(Baseline and Week 8)
- Digit Span Backward Total Correct(Baseline and Week 8)
- Finger Tapping Score--Dominant Hand(Baseline and Week 8)
- Finger Tapping Score--Non-Dominant Hand(Baseline and Week 8)
- Short-Term Memory Composite Score(Baseline and Week 8)
- CVLT Short Delay Free Recall(Baseline and Week 8)
- Card Rotations Test Score(Baseline and Week 8)
- Change in Short-term Memory and Executive Function Composite Scores.(Baseline and 8 weeks)