NCT04289727

Brief Summary

The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

February 2, 2020

Last Update Submit

January 29, 2026

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in microarchitecture by HR-pQCT

    Measures of HRpQCT

    Two Years

  • Change in bone mineral density by Dual X-ray Absorptometry (DXA)

    Measures of DXA

    Two Years

Study Arms (2)

Group 1

Those with Type 1 Diabetes.

Group 2

Those without Type 1 Diabetes.

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

40 children and adolescents between the age of 8 to 14 years with type 1 diabetes and 40 children and adolescents between the age of 8 to 14 years without type 1 diabetes.

You may qualify if:

  • \- Children within 2 years preceding the onset of the pubertal growth spurt
  • \- documentation of β-cell autoimmunity and need for insulin replacement

You may not qualify if:

  • Estimated glomerular filtration rate (eGFR)\< 60 ml/mim
  • (OH)D level \< 20 ng/ml.
  • Celiac disease
  • Autoimmune thyroid disease
  • Addison's disease
  • History of pathological fractures
  • \-- Disorders associated with altered skeletal structure or function
  • Bone active drugs in past year
  • Diabetes of other or unclear etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center-Harkness Pavillion

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

am fasting Comprehensive Metabolic Panel (CMP) including liver function, HbA1c and 25OHD.

Study Officials

  • Mishaela Rubin, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 28, 2020

Study Start

January 1, 2020

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

US(1)