NCT01870557

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: Jakob Starup Linde · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2013-06-06
• Last updated: 2015-05-28

Locations

2 sites across 1 country: Denmark