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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
Sponsor:
Collaborators:
Universidad Miguel Hernandez de Elche
University of Alicante
Information provided by (Responsible Party):
Enrique Roche, University Hospital A Coruña

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

Condition or disease
Type 1 Diabetes Physical Activity

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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
Whole blood


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Ages Eligible for Study:   7 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

19 subjects from 26 with recent onset of type 1 diabetes completed the 2 years study in the Endocrinology Service of the University Hospital Complex of A Coruña (Spain).

The mean age of group A was 21.9±4.2 years and included 8 individuals, 5 men and 3 women diagnosed at the moment of onset by hyperglycaemia + ketoacidosis (n=4), ketoacidosis (n=2) or hyperglycaemia (n=2). The mean age of group S was 23.3±2.2 years and included 11 individuals, 7 men and 4 women diagnosed at the moment of onset by hyperglycaemia + ketoacidosis (n=3), ketoacidosis (n=7) or hyperglycaemia (n=1).

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789190


Locations
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Spain
Endocrinology Service of the University Hospital Complex of A Coruña (Spain)
A Coruna, Spain
Sponsors and Collaborators
University Hospital A Coruña
Universidad Miguel Hernandez de Elche
University of Alicante
Investigators
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Principal Investigator: Teresa Martinez-Ramonde, MD Endocrinology Departmente, Hospital A Coruna
Additional Information:
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Responsible Party: Enrique Roche, PhD, University Hospital A Coruña
ClinicalTrials.gov Identifier: NCT01789190    
Other Study ID Numbers: PS09/01093
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013
Keywords provided by Enrique Roche, University Hospital A Coruña:
Honeymoon
Type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases