Type 1 DiabetesHoneymoonNCT01789190
Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects
An observational study of Type 1 Diabetes and Physical Activity, run by University Hospital A Coruña at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Type 1 Diabetes, Physical Activity
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Feb 2013
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- Not capable to provide data and blood samples required for study follow up.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Endocrinology Service of the University Hospital Complex of A Coruña (Spain)
A Coruña, A Coruna
About this study
Official title: 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
Read the 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.
- Conditions
- Type 1 Diabetes, Physical Activity
- Keywords
- Honeymoon, Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionFeb 2013
Why it stopped: The study has concluded normally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital A Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche, University of Alicante
- Responsible party
- Principal investigator, Enrique Roche, University Hospital A Coruña
- Investigators
- Teresa Martinez-Ramonde, MD, Principal investigator, Endocrinology Departmente, Hospital A Coruna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789190
- Sponsor's protocol ID
- PS09/01093
- Acronym
- Honeymoon
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study: Regular Physical Exercise Extends Honeymoon Phase in Type 1 Diabetes Subjects
- ClinicalTrials.gov ID
- NCT01789190
- Acronym / sponsor ID
- Honeymoon / PS09/01093
- Conditions
- Type 1 Diabetes, Physical Activity
- Keywords
- Honeymoon, Type 1 diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study has concluded normally
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital A CoruñaUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche, University of Alicante
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not capable to provide data and blood samples required for study follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
To study the influence of regular physical activity on the control of the inflammation process associated to type 1 diabetes.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The study has concluded normally). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- PDF of the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Martinez-Ramonde, MD principal investigator
Endocrinology Departmente, Hospital A Coruna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Physical Activity, run by University Hospital A Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has concluded normally). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.