Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:45 - 70
Updated:2/18/2017
Start Date:March 2016
End Date:April 2017
Contact:Prakriti Joshee, BS
Email:prakriti.joshee@ucdenver.edu
Phone:303-724-9925

Use our guide to learn which trials are right for you!

The study is aimed 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 aimed to find link between bone density and
cardiovascular risk.

This study has only one visit. All participants will undergone bone density testing using
dual energy x-ray absorptiometry (DEXA) machine and measurement of carotid intima media
thickness (a marker of carotid atherosclerosis) using carotid ultrasound.

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 aged between 45 years and 70 years. 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.
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Viral Shah, MD
Phone: 303-724-9925
?
mi
from
Aurora, CO
Click here to add this to my saved trials