Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects (Honeymoon)
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|ClinicalTrials.gov Identifier: NCT01789190|
Recruitment Status : Terminated (The study has concluded normally)
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
|Condition or disease|
|Type 1 Diabetes Physical Activity|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||19 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||Observational Study: Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
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.
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
- We aimed to study the influence of regular physical activity on the prolongation of the honeymoon period in type 1 diabetic patients by determining circulating parameters. [ Time Frame: 2 years ]Circulating parameters to assess diabetes management: HbA1c was determined by immunoanalysis. C-peptide was determined by radioimmunoassay using the Coat-a-Count kit (Diagnosis Products Corporation, LA). Protein carbonyl derivatives were calculated by adapting the method developed by Levine (1994) (12)
- To study the influence of regular physical activity on the control of the inflammation process associated to type 1 diabetes. [ Time Frame: 2 years ]Inflammation was assessed by determining circulating cytokines were in plasma by Flow Cytometry (FACSCalibur, Benton & Dickinson Bioscience) through the FlowcytomixTM Multiplex Test (eBioscience) (n=3). The following cytokines were analysed for each patient: IL (interleukin)-1beta, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12p70, IL-13, IL-17a, IL-22, TNF (tumor necrosis factor)-alpha and INF (interpheron)-gamma.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789190
|Endocrinology Service of the University Hospital Complex of A Coruña (Spain)|
|A Coruna, Spain|
|Principal Investigator:||Teresa Martinez-Ramonde, MD||Endocrinology Departmente, Hospital A Coruna|