Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Postmenopausal women with T1D

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

Bone density and carotid ultrasound

Intervention Type OTHER

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

Bone density and carotid ultrasound

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes