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Trial record 32 of 2829 for:    Type 1 Diabetes

Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02693964
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Other: Bone density and carotid ultrasound

Detailed 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.


Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
Actual Study Start Date : March 2016
Primary Completion Date : July 2017
Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Postmenopausal women with T1D
Postmenopausal between 45-70 years of age and having T1D for at least 10 years
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.
Postmenopausal women without diabetes
Postmenopausal between 45-70 years of age without diabetes
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.


Outcome Measures

Primary Outcome Measures :
  1. Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls [ Time Frame: at baseline ]
    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.

  2. Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls [ Time Frame: at baseline ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: at baseline ]
    Bone markers such as osteocalcin, osteopontin and osteoprotogerin and inflammatory markers such as hs-CRP, IL-2, IL-6 and TNF-α will differ by diabetes status and will be associated with the lower bone density and higher cardiovascular risk in postmenopausal women with T1D.

  2. 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. [ Time Frame: at baseline ]
    Bone markers such as osteocalcin, osteopontin and osteoprotogerin and inflammatory markers such as hs-CRP, IL-2, IL-6 and TNF-α will differ by diabetes status and will be associated with the lower bone density and higher cardiovascular risk in postmenopausal women with T1D.

  3. Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness) [ Time Frame: at baseline ]
    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.


Biospecimen Retention:   Samples Without DNA
blood and urine samples

Eligibility Criteria

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women with or without type 1 diabetes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693964


Locations
United States, Colorado
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Viral Shah, MD University of Colorado, Denver
More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02693964     History of Changes
Other Study ID Numbers: 15-1854
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Type 1 Diabetes
Menopause
Cardiovascular Risk
Bone Density

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases