Glycemic Response to Road Cycling in Type 1 Diabetes

July 20, 2011 updated by: Team Type 1, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Professional cyclists on TeamType 1 cycling teams

Description

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)

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

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

Sponsor

Team Type 1, Inc.

Investigators

  • Principal Investigator: Juan P Frias, MD, Team Type 1, Inc.

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

May 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT1-001

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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