Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02693964

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Other: Bone density and carotid ultrasound

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

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Postmenopausal women with T1D Postmenopausal between 45-70 years of age and having T1D for at least 10 years	Other: Bone density and carotid ultrasound 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.
Postmenopausal women without diabetes Postmenopausal between 45-70 years of age without diabetes	Other: Bone density and carotid ultrasound 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.

Arm

Intervention/Treatment

Postmenopausal women with T1D

Postmenopausal between 45-70 years of age and having T1D for at least 10 years

Other: Bone density and carotid ultrasound

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.

Postmenopausal women without diabetes

Postmenopausal between 45-70 years of age without diabetes

Other: Bone density and carotid ultrasound

Outcome Measures

Primary Outcome Measures

Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls [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 carotid intima media thickness between postmenopausal women with type 1 diabetes and controls [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

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 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.