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Bone Health in Youth With Type 1 Diabetes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140424
Recruitment Status : Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Deborah Mitchell, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date May 13, 2014
First Posted Date May 16, 2014
Last Update Posted Date July 9, 2019
Study Start Date August 2013
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2019)
Rate of bone mineral accrual [ Time Frame: 0, 12, 24 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.
Original Primary Outcome Measures
 (submitted: May 14, 2014)
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.
Change History Complete list of historical versions of study NCT02140424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 2, 2019)
  • 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.
  • 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.
  • Change bone microarchitectural parameters in patients with diabetes vs. controls [ Time Frame: 0 and 24 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.
Original Secondary Outcome Measures
 (submitted: May 14, 2014)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2019)
  • Association of glycemic control with bone mineral accrual [ Time Frame: 0 and 24 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.
  • Association of bone mineral accrual with moderate-to-vigorous physical activity [ Time Frame: 0 and 24 months ]
    activity will be assessed with accelerometers. The association of bone accrual among youth with and without diabetes will be assessed by correlation analysis.
Original Other Pre-specified Outcome Measures
 (submitted: May 14, 2014)
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.
 
Descriptive Information
Brief Title Bone Health in Youth With Type 1 Diabetes
Official Title Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
Brief Summary This is an observational study of children and young adults ages 6-20 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 will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum, plasma, urine
Sampling Method Non-Probability Sample
Study Population youth and young adults with type 1 diabetes and healthy controls
Condition
  • Type 1 Diabetes
  • Osteoporosis
Intervention Not Provided
Study Groups/Cohorts
  • youth with type 1 diabetes
  • healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 5, 2019)
234
Original Estimated Enrollment
 (submitted: May 14, 2014)
66
Estimated Study Completion Date July 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 6-20 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02140424
Other Study ID Numbers 2013P000985
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Deborah Mitchell, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Deborah M Mitchell, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2019