Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects (Honeymoon)

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

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

Study Overview

• Status: Terminated
• Conditions: Physical Activity; Type 1 Diabetes

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain
    • Endocrinology Service of the University Hospital Complex of A Coruña (Spain)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital A Coruña
• Collaborators: Universidad Miguel Hernandez de Elche; University of Alicante
• Investigators: Principal Investigator: Teresa Martinez-Ramonde, MD, Endocrinology Departmente, Hospital A Coruna

Publications and helpful links

Helpful Links

• PDF of the study

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Honeymoon
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: PS09/01093