Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

University of Colorado, Denver100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Diabetes Mellitus, Type 1

Interventions

Bone density and carotid ultrasoundOTHER

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.

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 30. * 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.

Locations (1)

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: at baseline

Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls

Time frame: at baseline

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)

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.

Time frame: 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.

Time frame: at baseline

Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness)

Data from ClinicalTrials.gov

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