Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693964
• Other study ID #: 15-1854
• Status: Completed
• Start date: March 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: January 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Davis Center for Diabetes	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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-a 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
Secondary	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-a 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
Secondary	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