Bone Health in Youth With Type 1 Diabetes

October 7, 2020 updated by: Deborah Mitchell, MD, Massachusetts General Hospital

Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

youth and young adults with type 1 diabetes and healthy controls

Description

Inclusion Criteria:

  • Age 6-20 years
  • Out of honeymoon period (cohort with diabetes)

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy controls
youth with type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 12, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
0 and 24 months
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.
0 and 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 and 24 months
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.
0 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P000985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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