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Trial record 46 of 2791 for:    Type 1 Diabetes

Bone Health in Youth With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02140424
Recruitment Status : Recruiting
First Posted : May 16, 2014
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an observation study of girls ages 10-16 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.

Condition or disease
Type 1 Diabetes Osteoporosis

Study Design

Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
Study Start Date : August 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
youth with type 1 diabetes
healthy controls


Outcome Measures

Primary Outcome Measures :
  1. Rate of bone mineral accrual [ Time Frame: 0 and 12 months ]
    Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.


Secondary Outcome Measures :
  1. Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls [ Time Frame: Baseline ]
    Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness.

  2. Rate of bone mineral accrual [ Time Frame: 0 and 24 months ]
    Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 24 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.

  3. Change bone microarchitectural parameters in patients with diabetes vs. controls [ Time Frame: 0 and 12 months ]
    Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at 0 and 12 months. Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness and percent change over 12 months will be calculated. Percent change will be compared in patients with diabetes and matched controls.


Other Outcome Measures:
  1. Association of glycemic control with bone mineral accrual [ Time Frame: 0 and 12 months ]
    Glycemic control will be assessed by hemoglobin A1c measurements at study visits and as part of routine diabetes care. An average hemoglobin A1c over the time of observation will be calculated using the trapezoidal rule. Association of glycemic control with bone mineral accrual as measured by DXA will be examined via regression analysis.


Biospecimen Retention:   Samples Without DNA
serum, plasma, urine

Eligibility Criteria

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
youth with type 1 diabetes and healthy controls
Criteria

Inclusion Criteria:

  • Female
  • Age 10-16 years
  • Diagnosed with type 1 diabetes > 1 year (diabetic cohort)

Exclusion Criteria:

  • BMI<5th percentile for age
  • BMI>95th percentile for age
  • Celiac disease
  • Hyperthyroidism, uncontrolled hypothyroidism
  • History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
  • Anemia (Hgb <11)
  • Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)
Contacts and Locations

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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): NCT02140424


Contacts
Contact: Deborah M Mitchell, MD 617-724-2034 dmmitchell@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Deborah M Mitchell, MD    617-724-2034    dmmitchell@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Deborah M Mitchell, MD Massachusetts General Hospital
More Information

Responsible Party: Deborah Mitchell, MD, Instructor in Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02140424     History of Changes
Other Study ID Numbers: 2013P000985
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Deborah Mitchell, MD, Massachusetts General Hospital:
type 1 diabetes
osteoporosis
children

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Osteoporosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases