Clinical trial NCT01789190: Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects
Official title: Observational Study: Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes
Physical Activity
Keywords: Honeymoon
Type 1 diabetes
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
Collaborators: name: Universidad Miguel Hernandez de Elche
name: University of Alicante
First posted: 2013-02-11
Enrollment: 19
Sex: ALL
Minimum age (years): 7
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: To study the influence of regular physical activity on the control of the inflammation process associated to type 1 diabetes.
timeFrame: 2 years
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Endocrinology Service of the University Hospital Complex of A Coruña (Spain)
Study officials:
affiliation: Endocrinology Departmente, Hospital A Coruna
name: Teresa Martinez-Ramonde, MD
role: PRINCIPAL_INVESTIGATOR
References: