Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects

Type 1 Diabetes Clinical Trial

— Honeymoon  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01789190
• Other study ID #: PS09/01093
• Status: Terminated
• Phase: N/A
• First received: February 5, 2013
• Last updated: February 7, 2013
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University Hospital A Coruña
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 30 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Physical Activity
• Type 1 Diabetes

Locations

Country	Name	City	State
Spain	Endocrinology Service of the University Hospital Complex of A Coruña (Spain)	A Coruna

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital A Coruña	Universidad Miguel Hernandez de Elche, University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   PDF of the study