Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects

NCT01789190 | Terminated DMC

• 1 other identifier: PS09/01093
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 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

Conditions

Type 1 Diabetes; Physical Activity

Keywords

Honeymoon; Type 1 diabetes

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• To study the influence of regular physical activity on the control of the inflammation process associated to type 1 diabetes.

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• \- Not capable to provide data and blood samples required for study follow up.

Sponsors & Collaborators

• University Hospital A Coruña: lead
• Universidad Miguel Hernandez de Elche: collaborator
• University of Alicante: collaborator

Study Sites (1)

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

A Coruña, A Coruna, Spain

Location

Related Links

• PDF of the study

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Teresa Martinez-Ramonde, MD

  Endocrinology Departmente, Hospital A Coruna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

ES (1)