Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects

NCT ID: NCT01789190

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-02-28

Brief Summary

In diabetes, the honeymoon period is characterized by the presence of a functional reserve of β-cells that favours an adequate metabolic control and low insulin needs in order to control glycaemia. Therefore, the extension of this period could have evident benefits in diabetes management. The investigators aimed to study the influence of regular physical activity on the prolongation of the honeymoon period

Detailed Description

Observational study of two groups of type 1 diabetic patients from onset to a two-year period. One group exercised regularly (5 or more hours/week) before onset and continued doing so with the same regularity (group A). The second group either did not perform physical activity or did so sporadically (group S).

Consultations were initially performed on a weekly basis for the first month, then once a month for the remaining period. In each consultation, patients were asked about diet accomplishment, glycaemia monitoring, insulin injections and exercise performance. All individuals from group A declared to practice regularly intervallic routines, playing team sports (basketball for n=1 and soccer for n=6). Only one individual declared to perform aerobic exercise (long distance running and swimming). At the end of the first year a second blood sample was extracted in the same conditions from each individual to determine the same parameters. Exercise routine accomplishment and follow-up of diet and insulin injections was followed monthly during one more year. At the end of this period, the study was considered finished and the last blood extraction was performed in order to measure the same parameters. Other subjects were excluded because they were not capable to provide data required for study follow up.

Conditions

Type 1 Diabetes; Physical Activity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group S (sedentary)

Group S included patients that did not perform any physical activity at the moment of onset, continuing with the same habits during the subsequent observational period.

No interventions assigned to this group

Group A (active)

The inclusion criteria for group distribution took in account the principles of the American College of Sports Medicine, considering as active physical activity to practice a moderate-vigorous exercise during 1h, 5 days or more/week. In this context, a sedentary or less active person should be a person that practices any or less than 5h weekly

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Undergo type 1 diabetes.
• To practice a moderate-vigorous exercise during 1h, 5 days or more/week before onset and continuing practicing for 2 more years for group A (active).
• To practice any or less than 5h weekly before and after onset for group S (sedentary).
• Capable to provide data and blood samples during follow up.

Exclusion Criteria

• Not capable to provide data and blood samples required for study follow up.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

University of Alicante

OTHER

Sponsor Role: collaborator

University Hospital A Coruña

OTHER

Sponsor Role: lead

Responsible Party

Enrique Roche

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Martinez-Ramonde, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Departmente, Hospital A Coruna

Locations

Endocrinology Service of the University Hospital Complex of A Coruña (Spain)

A Coruña, A Coruna, Spain

Countries

Spain

Related Links

https://sites.google.com/a/goumh.umh.es/clinicaltrials/anuncios

PDF of the study

Other Identifiers

PS09/01093

Identifier Type: -

Identifier Source: org_study_id