NCT01605149

Brief Summary

Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is unclear how and when it effects the bone density. The investigators are studying the effects of diabetes on bone mass compared to children without diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 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

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

May 22, 2012

Last Update Submit

March 25, 2014

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes

Study Arms (1)

Case

Patients with Type 1 Diabetes Mellitus

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with Type 1 DM

You may qualify if:

  • We will recruit children from age 5 to age 18 with a diagnosis of Type 1 DM. Children will have various lengths of time since diagnosis.

You may not qualify if:

  • We will exclude children on anticonvulsants or steroids and children with other concomitant illnesses that interfere with bone mass accrual, except for hypothyroidism on treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laura AG Armas, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

US(1)