Clinical trial NCT02693964: Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
Official title: Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Menopause
Cardiovascular Risk
Bone Density
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with or without type 1 diabetes

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.

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.

Eligibility 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.

Primary outcomes:
measure: Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls
timeFrame: at baseline
measure: Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls
timeFrame: at baseline
Secondary outcomes:
measure: 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)
timeFrame: at baseline
measure: 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.
timeFrame: at baseline
measure: Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness)
timeFrame: at baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Viral Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah VN, Shah CS, Snell-Bergeon JK. Type 1 diabetes and risk of fracture: meta-analysis and review of the literature. Diabet Med. 2015 Sep;32(9):1134-42. doi: 10.1111/dme.12734. Epub 2015 Jun 12.
citation: Dhaon P, Shah VN. Type 1 diabetes and osteoporosis: A review of literature. Indian J Endocrinol Metab. 2014 Mar;18(2):159-65. doi: 10.4103/2230-8210.129105.
citation: Shah VN, Joshee P, Sippl R, Pyle L, Vigers T, Carpenter RD, Kohrt W, Snell-Bergeon JK. Type 1 diabetes onset at young age is associated with compromised bone quality. Bone. 2019 Jun;123:260-264. doi: 10.1016/j.bone.2019.03.039. Epub 2019 Mar 29.