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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal women with T1D | Postmenopausal between 45-70 years of age and having T1D for at least 10 years |
| |
| Postmenopausal women without diabetes | Postmenopausal between 45-70 years of age without diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone density and carotid ultrasound | Other | All participants will be asked for relevant medical, personal, family and diabetes history, treatment and complications, and history of falls and fractures and will undergo measurement of bone density, carotid ultrasound and a blood draw. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls | 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. | at baseline |
| Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls | 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. | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Bone markers such as osteocalcin, osteopontin and osteoprotogerin and inflammatory markers such as hs-CRP, IL-2, IL-6 and TNF-α will differ by diabetes status and will be associated with the lower bone density and higher cardiovascular risk in postmenopausal women with T1D. |
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Inclusion Criteria:
Exclusion Criteria:
Chronic diseases, which can affect the BMD measurement such as:
Medications that can affect BMD results such as:
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Postmenopausal women with or without type 1 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Viral Shah, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26096918 | Background | Shah VN, Shah CS, Snell-Bergeon JK. Type 1 diabetes and risk of fracture: meta-analysis and review of the literature. Diabet Med. 2015 Sep;32(9):1134-42. doi: 10.1111/dme.12734. Epub 2015 Jun 12. | |
| 24741510 | Background | Dhaon P, Shah VN. Type 1 diabetes and osteoporosis: A review of literature. Indian J Endocrinol Metab. 2014 Mar;18(2):159-65. doi: 10.4103/2230-8210.129105. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015519 | Bone Density |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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blood and urine samples
|
| 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. | Bone markers such as osteocalcin, osteopontin and osteoprotogerin and inflammatory markers such as hs-CRP, IL-2, IL-6 and TNF-α will differ by diabetes status and will be associated with the lower bone density and higher cardiovascular risk in postmenopausal women with T1D. | at baseline |
| Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness) | 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. | at baseline |
| 30936041 | Background | Shah VN, Joshee P, Sippl R, Pyle L, Vigers T, Carpenter RD, Kohrt W, Snell-Bergeon JK. Type 1 diabetes onset at young age is associated with compromised bone quality. Bone. 2019 Jun;123:260-264. doi: 10.1016/j.bone.2019.03.039. Epub 2019 Mar 29. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |