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Completed

NCT Number: NCT01870557

Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)

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.

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Key information

Conditions

Diabetes Mellitus Bone Diseases Bone Diseases, Metabolic Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HbA1c

    Time frame: Baseline

    Long term blood glucose evaluation

  2. Bone Mineral Density (t-score)

    Time frame: Baseline

Secondary outcomes

  1. Biochemical Bone Markers

    Time frame: Baseline

  2. Sex-hormones

    Time frame: Baseline

  3. Electrolytes

    Time frame: Baseline

  4. Vitamin D (25ODH /1,25OHD)

    Time frame: Baseline

  5. Results from the HRpQCT scan including Trabecular and Cortical state

    Time frame: Baseline

    Not available for participants at center Aalborg

  6. Markers of fat tissue and glycemic status

    Time frame: Baseline

    Including Insulin level, adiponectin

  7. Verterbral fracture assessment

    Time frame: Baseline

    A part of the DXA if vertebral fracture assessment is available. For patients at center Aalborg this will be evaluated through X-ray.

  8. Lifestyle and Medical history

    Time frame: Baseline

    Assessed by structured interview and questionnaire. Information on alcohol consumption, smoking, pharmaceutical use, diabetes complications, diabetes duration, physical activity, previous fractures are collected.

Other outcomes

  1. urine creatinine albumin ratio

    Time frame: Baseline

    Collected by both 24 hour urine samples and a urine sample.

Sponsors and collaborators

Lead sponsor

Jakob Starup Linde

Other

Registry information

Acronym: Diabone

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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