Diabetes Mellitus, Type 2NCT02400515
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals
A study testing Exercise in people with Diabetes Mellitus, Type 2, run by University of Campinas, Brazil.
Trial summary
This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jun 2008
- Phase
- Interventional
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having normal physical examinations,
- no participation in regular, moderate or intensive exercise for at least 6 months before the study and
- not be following a diet
Who cannot join
- the use of insulin and beta-blocker medications and
- the functional inability to perform exercise
About this study
Official title: Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals
This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.
Read the detailed description
This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exercise
- Keywords
- Exercise, Exercise Therapy, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
This is a quasi-experimental study and the same group was evaluated before and after the exercise.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Exercise | Other | Aerobic physical exercise was applied during 3 months, 3x/week on women with type 2 diabetic. The evaluation occurred before and after exercise in the same (and only) group, considering that this is a quasi-experimental study. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.
Measured: 3 months
Secondary outcomes (7)
Systolic and Diastolic blood pressure
Change in Systolic and Diastolic blood pressure were evaluated before and after physical exercise, during 3 months.
Measured: 3 months
Heart Rate measurement
Change in heart rate was evaluated before, during and after physical exercise, during 3 months.
Measured: 3 months
Glycated hemoglobin levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glycated hemoglobin test.
Measured: 3 months
Proteinuria levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for proteinuria test.
Measured: 3 months
Triglycerides levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for triglycerides test.
Measured: 3 months
High Density Level (HDL) Cholesterol levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for High Density Level Cholesterol test.
Measured: 3 months
Low Density Level (LDL) Cholesterol levels
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Low Density Level Cholesterol test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Sanches, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400515
- Sponsor's protocol ID
- 030/2007
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT02400515
- Acronym / sponsor ID
- 030/2007
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Exercise Therapy, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Mar 2015 (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.
This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.
Detailed description
This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate Exercise | Other | Other: ExerciseAerobic physical exercise was applied during 3 months, 3x/week on women with type 2 diabetic. The evaluation occurred before and after exercise in the same (and only) group, considering that this is a quasi-experimental study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having normal physical examinations,
- no participation in regular, moderate or intensive exercise for at least 6 months before the study and
- not be following a diet
Key exclusion criteria (2 listed)
- the use of insulin and beta-blocker medications and
- the functional inability to perform exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThis is a quasi-experimental study and the same group was evaluated before and after the exercise. | Other | Moderate Exercise |
Primary outcome
Glucose levels
Time frame: 3 months
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.
7 secondary outcomes
Systolic and Diastolic blood pressure
Time frame: 3 months
Heart Rate measurement
Time frame: 3 months
Glycated hemoglobin levels
Time frame: 3 months
Proteinuria levels
Time frame: 3 months
Triglycerides levels
Time frame: 3 months
High Density Level (HDL) Cholesterol levels
Time frame: 3 months
Low Density Level (LDL) Cholesterol levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Diabetes Mellitus, Type 2, run by University of Campinas, Brazil.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose levels (time frame: 3 months). 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 27 Mar 2015.