Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Completed

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02693964

Run by

University of Colorado, Denver

People needed

100

Starts

2016-03-01

Expected to finish

2017-07-31

Last updated by the study team

2020-01-28

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barbara Davis Center for Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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