- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01870557
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2) (Diabone)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aalborg, Denmark, 9000
- Department of Endocrinology, Aalborg University Hospital
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Aarhus, Denmark, 8000
- Department of Endocrinology and Internal Medicine, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Diabetes Mellitus type 1
n=100
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Diabetes Mellitus type 2
n=100
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Baseline
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Long term blood glucose evaluation
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Baseline
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Bone Mineral Density (t-score)
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical Bone Markers
Time Frame: Baseline
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Baseline
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Sex-hormones
Time Frame: Baseline
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Baseline
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Electrolytes
Time Frame: Baseline
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Baseline
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Vitamin D (25ODH /1,25OHD)
Time Frame: Baseline
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Baseline
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Results from the HRpQCT scan including Trabecular and Cortical state
Time Frame: Baseline
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Not available for participants at center Aalborg
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Baseline
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Markers of fat tissue and glycemic status
Time Frame: Baseline
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Including Insulin level, adiponectin
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Baseline
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Verterbral fracture assessment
Time Frame: Baseline
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A part of the DXA if vertebral fracture assessment is available.
For patients at center Aalborg this will be evaluated through X-ray.
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Baseline
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Lifestyle and Medical history
Time Frame: Baseline
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Assessed by structured interview and questionnaire.
Information on alcohol consumption, smoking, pharmaceutical use, diabetes complications, diabetes duration, physical activity, previous fractures are collected.
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urine creatinine albumin ratio
Time Frame: Baseline
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Collected by both 24 hour urine samples and a urine sample.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Vestergaard, Professor MD PhD DrMedSc, Aalborg University Hospital
- Principal Investigator: Kim Brixen, Professor MD PhD DrMedSc, Odense University Hospital
- Study Chair: Søren Gregersen, MD PhD, Aarhus University Hospital
- Study Chair: Bente Lomholt Langdahl, Professor MD PhD DrMedSc, Aarhus University Hospital
- Study Chair: Ellen-Magrethe Hauge, MD PhD, Aarhus University Hospital
Publications and helpful links
General 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.
- Starup-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.
- Starup-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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36777
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