Diabetes Mellitus, Type 1NCT02693964
Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Bone density and carotid ultrasound
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women with or without type 1 diabetes
Who may be able to join
- 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.
Who cannot join
- Chronic diseases, which can affect the BMD measurement such as:
- Uncontrolled coeliac or thyroid disease,
- Addison's disease,
- Malabsorption syndrome,
- Rheumatologic disorder,
- Parathyroid disorders,
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Bone density and carotid ultrasound
- Keywords
- Type 1 Diabetes, Menopause, Cardiovascular Risk, Bone Density
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone density and carotid ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women with T1D | Postmenopausal between 45-70 years of age and having T1D for at least 10 years Receives: Other: Bone density and carotid ultrasound | |
| Postmenopausal women without diabetes | Postmenopausal between 45-70 years of age without diabetes Receives: Other: Bone density and carotid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls
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.
Measured: at baseline
Difference in carotid intima media thickness between postmenopausal women with type 1 diabetes and controls
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.
Measured: at baseline
Secondary outcomes (3)
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)
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.
Measured: at baseline
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.
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.
Measured: at baseline
Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness)
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viral Shah, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693964
- Sponsor's protocol ID
- 15-1854
- Status last verified
- Jan 2020
- First submitted
- 18 Feb 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26096918Dhaon 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.
PubMed 24741510Shah 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.
PubMed 30936041
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02693964
- Acronym / sponsor ID
- 15-1854
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Menopause, Cardiovascular Risk, Bone Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women with T1D | – | Other: Bone density and carotid ultrasoundPostmenopausal between 45-70 years of age and having T1D for at least 10 years |
| Postmenopausal women without diabetes | – | Other: Bone density and carotid ultrasoundPostmenopausal between 45-70 years of age without diabetes |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with or without type 1 diabetes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Chronic diseases, which can affect the BMD measurement such as:
- Medications that can affect BMD results such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone density and carotid ultrasoundAll 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. | Other | Postmenopausal women with T1D, Postmenopausal women without diabetes |
Primary outcome
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.
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.
3 secondary outcomes
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
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
Correlation between biomarkers with cardiovascular risk measures (carotid intima media thickness)
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 26096918Shah 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.
- Background: PubMed 24741510Dhaon 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.
- Background: PubMed 30936041Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viral Shah, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in bone mineral density between postmenopausal women with type 1 diabetes and controls (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693964, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.