Diabetes MellitusDiaboneNCT01870557
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
An observational study of Diabetes Mellitus and Osteoporosis, run by Jakob Starup Linde at 2 sites in Denmark.
Trial summary
Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans. Methods: This is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Osteoporosis, Osteopenia
- How many people
- 197 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2013to May 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 Diabetes Mellitus patients. 100 with type 1 diabetes and 100 with type 2 diabetes. Of the 100 type 2 diabetes patients half should be treated with insulin (n=50) and the other half treated with other oral antidiabetics and not insulin.
Who may be able to join
- Type 1 or type 2 diabetes.
- Age ≥ 50 years.
- Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.
- HbA1c level≥ 7 % through the previous six months.
- BMI between 19 og 35.
- Specific inclusion criteria for type 2 diabetes:
- Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs.
- Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs.
Who cannot join
- HbA1C > 10%
- Pregnancy.
- Metal implanted at both ankles and wrists.
- Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.
- Patients with a bone disease other than osteoporosis.
- Vertebral fracture visible by vertebral fracture assessment (VFA).
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- Patients with renal disease defined by estimated glomerular filtration rate(eGFR) < 50.
- Other medical disease in unstable phase (fx. cancer, hyperthyroidism).
- Heart failure; New York Heart Association (NYHA) class IV.
- Patients which the investigator does not believe is fit to participate in the study
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Endocrinology, Aalborg University Hospital
Aalborg, 9000
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, 8000
About this study
Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans.
Methods:
Read more
This is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of examinations including:
- Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.
- 24 hour urine sample to analyze bone markers and kidney function.
- Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.
Participants:
100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg, Aarhus and Odense, general practitioners and flyers.
Read the detailed description
Diabetes Mellitus and Osteoporosis are common conditions. Patients with Diabetes Mellitus are known to have more fractures than their non-diabetic counterparts. However bone mineral density (BMD) which is the most commonly used measure of fracture risk seems to be insensitive in diabetes, thus BMD is lowered in type 1 diabetes but not enough to explain an almost seven fold in fracture risk. BMD is increased in type 2 diabetes although they still have an increased fracture risk.
The investigators investigate this paradox in diabetes by assessing type 1 and type 2 diabetes patients bone status by blood- and urine samples (assessing markers of bone- and glycemic state) and two types of bone scans comprising of DXA and HRpQCT scan.
The diabetes mellitus patients are recruited from outpatients clinics in the three study sites (Aalborg, Aarhus and Odense) as well as general practitioners and by flyers and adds.
- Conditions
- Diabetes Mellitus, Osteoporosis, Osteopenia
- Keywords
- Diabetes Mellitus, Bone, Bone Status, Glycemic Markers, Osteoporosis, Osteopenia
- Medical subject headings
- Diabetes Mellitus, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus type 1 | n=100 | |
| Diabetes Mellitus type 2 | n=100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Long term blood glucose evaluation
Measured: Baseline
Bone Mineral Density (t-score)
Measured: Baseline
Secondary outcomes (8)
Biochemical Bone Markers
Measured: Baseline
Sex-hormones
Measured: Baseline
Electrolytes
Measured: Baseline
Vitamin D (25ODH /1,25OHD)
Measured: Baseline
Results from the HRpQCT scan including Trabecular and Cortical state
Not available for participants at center Aalborg
Measured: Baseline
Markers of fat tissue and glycemic status
Including Insulin level, adiponectin
Measured: Baseline
Verterbral fracture assessment
A part of the DXA if vertebral fracture assessment is available. For patients at center Aalborg this will be evaluated through X-ray.
Measured: Baseline
Lifestyle and Medical history
Assessed by structured interview and questionnaire. Information on alcohol consumption, smoking, pharmaceutical use, diabetes complications, diabetes duration, physical activity, previous fractures are collected.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionMay 2015
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 MellitusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakob Starup Linde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakob Starup Linde, Aarhus University Hospital
- Investigators
- Peter Vestergaard, Professor MD PhD DrMedSc, Principal investigator, Aalborg University HospitalKim Brixen, Professor MD PhD DrMedSc, Principal investigator, Odense University HospitalSøren Gregersen, MD PhD, Study chair, Aarhus University HospitalBente Lomholt Langdahl, Professor MD PhD DrMedSc, Study chair, Aarhus University HospitalEllen-Magrethe Hauge, MD PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870557
- Sponsor's protocol ID
- 36777
- Acronym
- Diabone
- Status last verified
- May 2015
- First submitted
- 29 May 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Starup-Linde JK, Viggers R, Langdahl B, Gregersen S, Lykkeboe S, Handberg A, Vestergaard P. Associations of Circulating Osteoglycin With Bone Parameters and Metabolic Markers in Patients With Diabetes. Front Endocrinol (Lausanne). 2021 Mar 15;12:649718. doi: 10.3389/fendo.2021.649718. eCollection 2021.
PubMed 33790870Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Bone Structure and Predictors of Fracture in Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):928-36. doi: 10.1210/jc.2015-3882. Epub 2016 Jan 12.
PubMed 26756117Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Differences in biochemical bone markers by diabetes type and the impact of glucose. Bone. 2016 Feb;83:149-155. doi: 10.1016/j.bone.2015.11.004. Epub 2015 Nov 10.
PubMed 26555635
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
- ClinicalTrials.gov ID
- NCT01870557
- Acronym / sponsor ID
- Diabone / 36777
- Conditions
- Diabetes Mellitus, Osteoporosis, Osteopenia
- Keywords
- Diabetes Mellitus, Bone, Bone Status, Glycemic Markers, Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Jakob Starup LindeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Jun 2013 (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.
Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans.
Methods:
This is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of examinations including:
- Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.
- 24 hour urine sample to analyze bone markers and kidney function.
- Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.
Participants:
100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg, Aarhus and Odense, general practitioners and flyers.
Detailed description
Diabetes Mellitus and Osteoporosis are common conditions. Patients with Diabetes Mellitus are known to have more fractures than their non-diabetic counterparts. However bone mineral density (BMD) which is the most commonly used measure of fracture risk seems to be insensitive in diabetes, thus BMD is lowered in type 1 diabetes but not enough to explain an almost seven fold in fracture risk. BMD is increased in type 2 diabetes although they still have an increased fracture risk.
The investigators investigate this paradox in diabetes by assessing type 1 and type 2 diabetes patients bone status by blood- and urine samples (assessing markers of bone- and glycemic state) and two types of bone scans comprising of DXA and HRpQCT scan.
The diabetes mellitus patients are recruited from outpatients clinics in the three study sites (Aalborg, Aarhus and Odense) as well as general practitioners and by flyers and adds.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus type 1 | – | –n=100 |
| Diabetes Mellitus type 2 | – | –n=100 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 Diabetes Mellitus patients. 100 with type 1 diabetes and 100 with type 2 diabetes. Of the 100 type 2 diabetes patients half should be treated with insulin (n=50) and the other half treated with other oral antidiabetics and not insulin.
Key inclusion criteria (8 listed)
- Type 1 or type 2 diabetes.
- Age ≥ 50 years.
- Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.
- HbA1c level≥ 7 % through the previous six months.
- BMI between 19 og 35.
Key exclusion criteria (10 listed)
- HbA1C > 10%
- Pregnancy.
- Metal implanted at both ankles and wrists.
- Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.
- Patients with a bone disease other than osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c
Time frame: Baseline
Long term blood glucose evaluation
Bone Mineral Density (t-score)
Time frame: Baseline
8 secondary outcomes
Biochemical Bone Markers
Time frame: Baseline
Sex-hormones
Time frame: Baseline
Electrolytes
Time frame: Baseline
Vitamin D (25ODH /1,25OHD)
Time frame: Baseline
Results from the HRpQCT scan including Trabecular and Cortical state
Time frame: Baseline
Markers of fat tissue and glycemic status
Time frame: Baseline
Verterbral fracture assessment
Time frame: Baseline
Lifestyle and Medical history
Time frame: 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 May 2015.
- Derived from this study: PubMed 33790870Starup-Linde JK, Viggers R, Langdahl B, Gregersen S, Lykkeboe S, Handberg A, Vestergaard P. Associations of Circulating Osteoglycin With Bone Parameters and Metabolic Markers in Patients With Diabetes. Front Endocrinol (Lausanne). 2021 Mar 15;12:649718. doi: 10.3389/fendo.2021.649718. eCollection 2021.
- Derived from this study: PubMed 26756117Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Bone Structure and Predictors of Fracture in Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):928-36. doi: 10.1210/jc.2015-3882. Epub 2016 Jan 12.
- Derived from this study: PubMed 26555635Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Differences in biochemical bone markers by diabetes type and the impact of glucose. Bone. 2016 Feb;83:149-155. doi: 10.1016/j.bone.2015.11.004. Epub 2015 Nov 10.
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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.
Peter Vestergaard, Professor MD PhD DrMedSc principal investigator
Aalborg University Hospital
Kim Brixen, Professor MD PhD DrMedSc principal investigator
Odense University Hospital
Søren Gregersen, MD PhD study chair
Aarhus University Hospital
2 sites 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 and Osteoporosis, run by Jakob Starup Linde at 2 sites in Denmark.
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 8 inclusion and 10 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
HbA1c (time frame: 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 NCT01870557, 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 May 2015.