Glycemic Response to Road Cycling in Type 1 Diabetes

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Team Type 1, Inc.

ClinicalTrials.gov Identifier:

NCT01398826

First received: July 19, 2011

Last updated: July 20, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2011

Last Updated Date

July 20, 2011

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01398826 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Glycemic Response to Road Cycling in Type 1 Diabetes

Official Title ^ICMJE

A Pilot Study Assessing the Glycemic Response and Its Relationship to Performance During Road Cycling in Elite Athletes With Type 1 Diabetes and Non-Diabetic Controls

Brief Summary

The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Professional cyclists on TeamType 1 cycling teams

Condition ^ICMJE

Type 1 Diabetes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

≥18 years of age
A1C ≤8.0% if diagnosed with type 1 DM

Exclusion Criteria:

If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party)
Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01398826

Other Study ID Numbers ^ICMJE

TT1-001

Has Data Monitoring Committee

Responsible Party

Juan Pablo Frias, MD, TeamType 1

Study Sponsor ^ICMJE

Team Type 1, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Juan P Frias, MD

Team Type 1, Inc.

Information Provided By

Team Type 1, Inc.

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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