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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
  Purpose

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.


Condition
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Team Type 1, Inc.:

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Professional cyclists on TeamType 1 cycling teams

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398826

Sponsors and Collaborators
Team Type 1, Inc.
Investigators
Principal Investigator: Juan P Frias, MD Team Type 1, Inc.
  More Information

No publications provided

Responsible Party: Juan Pablo Frias, MD, TeamType 1
ClinicalTrials.gov Identifier: NCT01398826     History of Changes
Other Study ID Numbers: TT1-001
Study First Received: July 19, 2011
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Team Type 1, Inc.:
Type 1 Diabetes
Exercise
Continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013