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

Diabetes Mellitus Clinical Trial

— Diabone  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870557
• Other study ID #: 36777
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: May 27, 2015
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Osteopenia
• Osteoporosis

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Aalborg University Hospital	Aalborg
Denmark	Department of Endocrinology and Internal Medicine, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Jakob Starup Linde

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	urine creatinine albumin ratio	Collected by both 24 hour urine samples and a urine sample.	Baseline	No
Primary	HbA1c	Long term blood glucose evaluation	Baseline	No
Primary	Bone Mineral Density (t-score)		Baseline	No
Secondary	Biochemical Bone Markers		Baseline	No
Secondary	Sex-hormones		Baseline	No
Secondary	Electrolytes		Baseline	No
Secondary	Vitamin D (25ODH /1,25OHD)		Baseline	No
Secondary	Results from the HRpQCT scan including Trabecular and Cortical state	Not available for participants at center Aalborg	Baseline	No
Secondary	Markers of fat tissue and glycemic status	Including Insulin level, adiponectin	Baseline	No
Secondary	Verterbral fracture assessment	A part of the DXA if vertebral fracture assessment is available. For patients at center Aalborg this will be evaluated through X-ray.	Baseline	No
Secondary	Lifestyle and Medical history	Assessed by structured interview and questionnaire. Information on alcohol consumption, smoking, pharmaceutical use, diabetes complications, diabetes duration, physical activity, previous fractures are collected.	Baseline	No