Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Bone density and carotid ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02693964

15-1854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Postmenopausal women with T1D

Description:

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

Treatment:

Other: Bone density and carotid ultrasound

Postmenopausal women without diabetes

Description:

Postmenopausal between 45-70 years of age without diabetes

Treatment:

Other: Bone density and carotid ultrasound