Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study: Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects

Conditions
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Type 1 Diabetes, Physical Activity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group S (sedentary)<br>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)<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the influence of regular physical activity on the control of the inflammation process associated to type 1 diabetes. | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Honeymoon, Type 1 diabetes