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

NCT01870557 | Completed

• 1 other identifier: 36777
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Diabetes Mellitus; Osteoporosis; Osteopenia

Keywords

Diabetes Mellitus; Bone; Bone Status; Glycemic Markers; Osteoporosis; Osteopenia

Outcome Measures

Primary Outcomes (2)

• HbA1c

  Long term blood glucose evaluation

  Baseline

• Bone Mineral Density (t-score)

  Baseline

Secondary Outcomes (8)

• Biochemical Bone Markers

  Baseline

• Sex-hormones

  Baseline

• Electrolytes

  Baseline

• Vitamin D (25ODH /1,25OHD)

  Baseline

• Results from the HRpQCT scan including Trabecular and Cortical state

  Baseline

Other Outcomes (1)

• urine creatinine albumin ratio

  Baseline

Study Arms (2)

Diabetes Mellitus type 1

n=100

Diabetes Mellitus type 2

n=100

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jakob Starup Linde: lead

Study Sites (2)

Department of Endocrinology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 33790870 DERIVED

• 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.

  PMID: 26756117 DERIVED

• 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.

  PMID: 26555635 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma EDTA Plasma Heparin Urine

MeSH Terms

Conditions

Diabetes Mellitus; Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Peter Vestergaard, Professor MD PhD DrMedSc

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Kim Brixen, Professor MD PhD DrMedSc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 6, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DK (2)