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

May 27, 2015 updated by: Jakob Starup Linde

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

Completed

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

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Endocrinology, Aalborg University Hospital
      • Aarhus, Denmark, 8000
        • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes Mellitus type 1
n=100
Diabetes Mellitus type 2
n=100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline
Long term blood glucose evaluation
Baseline
Bone Mineral Density (t-score)
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Bone Markers
Time Frame: Baseline
Baseline
Sex-hormones
Time Frame: Baseline
Baseline
Electrolytes
Time Frame: Baseline
Baseline
Vitamin D (25ODH /1,25OHD)
Time Frame: Baseline
Baseline
Results from the HRpQCT scan including Trabecular and Cortical state
Time Frame: Baseline
Not available for participants at center Aalborg
Baseline
Markers of fat tissue and glycemic status
Time Frame: Baseline
Including Insulin level, adiponectin
Baseline
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.
Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine creatinine albumin ratio
Time Frame: Baseline
Collected by both 24 hour urine samples and a urine sample.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jakob Starup Linde

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36777

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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