Phase 1
Completed N=12
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Diabetes Type 2 · Dementia
Source: ClinicalTrials.gov NCT03681691 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain — 12.28; 11.75 micromoles/min/100g tissue
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain |
12.28; 11.75 | — |
| PRIMARY FDG PET--Whole Brain |
8.74; 6.87 | — |
| PRIMARY Acetoacetate Uptake (AcAc) PET--Whole Brain |
0.031; 0.024 | — |
| PRIMARY AcAc PET--Whole Brain |
0.027; 0.028 | — |
| PRIMARY Change in Uptake of Glucose and Ketone Bodies in Whole Brain and Alzheimer's Disease-related Regions of Interest. |
— | — |
| SECONDARY Short-Term Memory Composite Score |
1.04; -0.52; 1.56; -0.56 | — |
| SECONDARY Executive Function Composite Score |
0.20; -0.10; 1.66; 0.30 | — |
| SECONDARY California Verbal Learning Task (CVLT) Long Delay Free Recall |
12.0; 10.83; 12.67; 13.17 | — |
| SECONDARY CVLT Short Delay Free Recall |
11.67; 10.00; 12.33; 11.67 | — |
| SECONDARY Benton Visual Retention Task (BVRT) Total Score |
8.67; 6.5; 9.33; 5.5 | — |
| SECONDARY Prospective Memory |
10.67; 5.83; 10.0; 8.17 | — |
| SECONDARY Verbal Fluency (Letters) |
48.67; 42.67; 46.33; 41.33 | — |
| SECONDARY Verbal Fluency Score (Fruits and Vegetables) |
31.0; 28.67; 32.67; 29.17 | — |
| SECONDARY Digit Span Forward Total Correct |
8.0; 7.5; 7.67; 7.67 | — |
| SECONDARY Digit Span Backward Total Correct |
4.0; 4.67; 6.0; 5.33 | — |
| SECONDARY Finger Tapping Score--Dominant Hand |
40.47; 43.53; 40.27; 44.07 | — |
| SECONDARY Finger Tapping Score--Non-Dominant Hand |
39.4; 38.2; 42.7; 41.7 | — |
| SECONDARY Card Rotations Test Score |
76.0; 90.67; 89.33; 97.0 | — |
| SECONDARY Change in Short-term Memory and Executive Function Composite Scores. |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03681691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.