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Glycemic Response to Road Cycling in Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Team Type 1, Inc..
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014