Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls
Study Overview
Brief Summary
The study is designed to evaluate the differences in bone mineral density (BMD) and Carotid Intima Media Thickness (CIMT) between postmenopausal women with type 1 diabetes (T1D) compared to postmenopausal women without diabetes.
Detailed Description
Type 1 diabetes (T1D) is an autoimmune disease requiring lifelong insulin treatment. Having T1D increases the risk of death, especially in women with T1D.
Heart disease and fractures due to osteoporosis (brittle bones) are the leading causes of death in women with T1D.
Since both diseases share certain common risk factors such as age, menopause, smoking, physical inactivity, and diabetes, this study is designed to find link between bone density and cardiovascular risk.
This study has only one visit. All participants will undergone bone density testing using a dual energy x-ray absorptiometry (DEXA) machine and measurement of carotid intima media thickness (a marker of carotid atherosclerosis) using carotid ultrasound.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •T1D as defined under CACTI study OR Controls as defined as no current diabetes (HbA1c < 6.5% and fasting blood glucose < 126 mg/dl, no diabetes diagnosis and no use of anti-diabetic medication),
- •Diabetes duration of 10 years or greater, and
- •Postmenopausal women. Menopause is defined as no menstrual periods for at least 12 consecutive months OR FSH greater than 40 IU/L on at least two occasions.
Exclusion Criteria
- •Chronic diseases, which can affect the BMD measurement such as:
- •Uncontrolled coeliac or thyroid disease,
- •Addison's disease,
- •Malabsorption syndrome,
- •Rheumatologic disorder,
- •Parathyroid disorders,
- •Cancer other than skin cancer, and
- •Chronic kidney disease with eGFR less than
- •Medications that can affect BMD results such as:
- •Oral or injectable steroid intake for more than 3 months,
- •Immunosuppressant and osteoanabolic or antiresorptive medications for osteoporosis treatment, and
- •Previous fractures or deformities making it difficult to perform DXA at hip and spine.
Outcomes
Primary Outcomes
Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls
Time Frame: at baseline
Postmenopausal women with T1D will have lower BMD at hip, lumbar spine and distal radius and higher cardiovascular risk as assessed by carotid intima media thickness (CIMT) compared to age and weight matched postmenopausal women without diabetes.
Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls
Time Frame: at baseline
Postmenopausal women with T1D will have lower BMD at hip, lumbar spine and distal radius and higher cardiovascular risk as assessed by carotid intima media thickness (CIMT) compared to age and weight matched postmenopausal women without diabetes.
Secondary Outcomes
- Differences in biomarkers (1): e.g. (bone specific alkaline phosphatase, Procollagen I Intact N-Terminal (P1NP), osteocalcin, C-terminal telopeptide (CTX): (Continued in Outcome 4)(at baseline)
- Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness)(at baseline)
- Differences in biomarkers (2): (Continued from Outcome 3) e.g. IL-2, IL-6 (Interleukin 2 and 6) and Tumor necrosis factor (TNF-alfa) between postmenopausal women with T1D and controls.(at baseline)