Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (DenSiFy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064437
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Claudia Gagnon, CHU de Quebec-Universite Laval

Brief Summary:

Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes.

This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Bone Fracture Bone Health Diagnostic Test: Clinical tests Diagnostic Test: Biochemical tests Diagnostic Test: DXA scan Diagnostic Test: AGE Reader

Layout table for study information
Study Type : Observational
Estimated Enrollment : 191 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Individuals with type 1 diabetes Diagnostic Test: Clinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.

Diagnostic Test: Biochemical tests
The investigators perform blood and urine tests in every participant.

Diagnostic Test: DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.

Diagnostic Test: AGE Reader
The investigators perform a skin AGE (advanced glycation end products) measurement with the AGE Reader machine in every participant.

Healthy controls Diagnostic Test: Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.

Diagnostic Test: Biochemical tests
The investigators perform blood and urine tests in every participant.

Diagnostic Test: DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.

Diagnostic Test: AGE Reader
The investigators perform a skin AGE (advanced glycation end products) measurement with the AGE Reader machine in every participant.




Primary Outcome Measures :
  1. Vertebral fracture detected with VFA [ Time Frame: Baseline ]
    Vertebral Fracture Assessment (VFA) software of dual-energy X-ray absorptiometry (DXA scan) is used to identify vertebral fractures. If there is evidence of a vertebral fracture on VFA, a lateral and anteroposterior spine X-ray will be obtained to confirm the VFA results.


Secondary Outcome Measures :
  1. Areal bone mineral density of the spine in g/cm2 [ Time Frame: Baseline ]
    Measured by DXA scan

  2. Areal bone mineral density of the spine, T-score [ Time Frame: Baseline ]
    Measured by DXA scan

  3. Areal bone mineral density of the spine, Z-score [ Time Frame: Baseline ]
    Measured by DXA scan

  4. Areal bone mineral density of proximal femur in g/cm2 [ Time Frame: Baseline ]
    Measured by DXA scan

  5. Areal bone mineral density of proximal femur, T-score [ Time Frame: Baseline ]
    Measured by DXA scan

  6. Areal bone mineral density of proximal femur, Z-score [ Time Frame: Baseline ]
    Measured by DXA scan

  7. Areal bone mineral density of total hip in g/cm2 [ Time Frame: Baseline ]
    Measured by DXA scan

  8. Areal bone mineral density of total hip, T-score [ Time Frame: Baseline ]
    Measured by DXA scan

  9. Areal bone mineral density of total hip, Z-score [ Time Frame: Baseline ]
    Measured by DXA scan

  10. Areal bone mineral density of distal radius in g/cm2 [ Time Frame: Baseline ]
    Measured by DXA scan

  11. Areal bone mineral density of distal radius, T-score [ Time Frame: Baseline ]
    Measured by DXA scan

  12. Areal bone mineral density of distal radius, Z-score [ Time Frame: Baseline ]
    Measured by DXA scan

  13. Lean mass (arm, leg, trunk, android, gynoid and total) [ Time Frame: Baseline ]
    Body composition measured by DXA scan

  14. Fat mass (arm, leg, trunk, android, gynoid and total) [ Time Frame: Baseline ]
    Body composition measured by DXA scan

  15. Skin AGE measurement [ Time Frame: Baseline ]
    Measured by AGE Reader

  16. C-telopeptide [ Time Frame: Baseline ]
    Bone turnover marker (serum)

  17. Sclerostin [ Time Frame: Baseline ]
    Bone turnover marker (serum)

  18. Osteocalcin [ Time Frame: Baseline ]
    Bone turnover marker (serum)


Other Outcome Measures:
  1. HbA1C [ Time Frame: Baseline ]
    Diabetes control marker

  2. Hemoglobin [ Time Frame: Baseline ]
    Blood level measurement

  3. Creatinine [ Time Frame: Baseline ]
    Blood level measurement

  4. Lipid panel [ Time Frame: Baseline ]
    Blood level measurement

  5. Thyroid-stimulating hormone (TSH) [ Time Frame: Baseline ]
    Blood level measurement

  6. Calcium [ Time Frame: Baseline ]
    Blood level measurement

  7. Albumine [ Time Frame: Baseline ]
    Blood level measurement

  8. Phosphate [ Time Frame: Baseline ]
    Blood level measurement

  9. 25-Hydroxyvitamin D [ Time Frame: Baseline ]
    Blood level measurement

  10. Parathormone (PTH) [ Time Frame: Baseline ]
    Blood level measurement

  11. Insulin like growth factor-1 (IGF-1) [ Time Frame: Baseline ]
    Blood level measurement

  12. Antitransglutaminase antibodies [ Time Frame: Baseline ]
    Blood level measurement

  13. Immunoglobulin A (IgA) [ Time Frame: Baseline ]
    Blood level measurement

  14. Follicle stimulating hormone (FSH, women) [ Time Frame: Baseline ]
    Blood level measurement

  15. Total testosterone (men) [ Time Frame: Baseline ]
    Blood level measurement

  16. Sex hormone-binding globulin (SHBG, men) [ Time Frame: Baseline ]
    Blood level measurement

  17. Microalbuminuria [ Time Frame: Baseline ]
    Urine microalbuminuria / urine creatinine ratio measurement


Biospecimen Retention:   Samples Without DNA
Blood (serum and plasma)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
127 individuals with type 1 diabetes and 64 healthy subjects
Criteria

Individuals with type 1 diabetes

Inclusion Criteria:

  • Diagnosis of type 1 diabetes for at least 5 years;
  • Age 20 years and older.

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal TSH, hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency);
  • Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, SGLT-2 (sodium-glucose cotransporter-2) inhibitors, thiazolidinediones;
  • Past medical history of traumatic vertebral fracture;
  • Inability to consent.

Healthy controls

Inclusion Criteria:

  • Age 20 years and older.

Exclusion Criteria:

  • As above (as individuals with diabetes), and :
  • Diagnosis of diabetes or prediabetes;
  • Celiac disease;
  • Chronic kidney disease (CrCl < 60 mL/min);
  • Any of theses medications in the past 6 months : biphosphonates, teriparatide, denosumab, calcitonin;
  • Past medical history of fragility fracture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064437


Contacts
Layout table for location contacts
Contact: Sarah Chouinard-Castonguay 418-525-4444 ext 48729 Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Locations
Layout table for location information
Canada, Quebec
Institut de recherches cliniques de Montréal (IRCM) Recruiting
Montréal, Quebec, Canada, H2W 1R7
Contact: Diane Mignault    514-987-5568    Diane.Mignault@ircm.qc.ca   
Canada
Centre de recherche du CHU de Québec - Université Laval Recruiting
Québec, Canada, G1V 4G2
Contact: Sarah Chouinard-Castonguay    418-525-4444 ext 48729    Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Layout table for investigator information
Principal Investigator: Claudia Gagnon, Dr CHU de Québec - Université Laval
Layout table for additonal information
Responsible Party: Claudia Gagnon, MD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT04064437    
Other Study ID Numbers: 2019-4550
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Fractures, Bone
Spinal Fractures
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Wounds and Injuries
Autoimmune Diseases
Immune System Diseases
Spinal Injuries
Back Injuries