Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-02 @ 7:41 AM
Study NCT ID:
NCT01870557
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
Sponsor:
Jakob Starup Linde
Organization:
Study Overview
Official Title:
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Diabone
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: