Type2 DiabetesEDDIENCT03423108
Exercise Dose-response for Diabetes in the Elderly
A study testing G150 and G300 in people with Type2 Diabetes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week vs 150min/week) will be compared against usual care. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- G150 and G300
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2018to 1 Aug 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of type 2 diabetes mellitus by HbA1c (> 6.5%) or capillary casual glycemia (> 126 mg/dL), oral glucose tolerance test or hypoglycemic drug use;
- HbA1c ≥ 7.5%;
- Verified ability to exercise;
- Physically inactive or regularly exercising for at least once a week.
Who cannot join
- HbA1c ≤ 12%;
- Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable cardioverter defibrillator);
- Major cardiovascular events 1 year previously to the enrollment (non-fatal myocardial infarction, coronary artery bypass surgery, cardiac catheterization, deep vein thrombosis, hospitalization or other severe health-related event);
- Chronic renal disease requesting dialysis;
- Severe macular injury (retinopathy) that disables patients to enroll an exercise program;
- Severe cognitive impairment (dementia) that disables patients to enroll an exercise program;
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- Deafness that disables patients to enroll an exercise program;
- Blindness that disables patients to enroll an exercise program;
- Progressive neurological disorders (Parkinson, multiple sclerosis, etc.) that disables patients to enroll an exercise program;
- Osteoarticular or muscular injuries or another health conditions which generate inability to carry on the interventions;
- Plans of moving to another city during the study;
- Living together with another person enrolled in the study;
- A medical report indicating exercise contraindication based on a cardiopulmonary exercise testing;
- Inability or refusal to give written consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Angélica De Nardi, MSc, +55 51 3359-6332, atnardi@hcpa.edu.br
Lucinéia Pfeifer, MSc, +55 51 3359-6332, lpfeifer@hcpa.edu.br
About this study
Official title: Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week vs 150min/week) will be compared against usual care. The entire study length will last 24 weeks, and assessments will be conducted at baseline, previously to the group allocation, at 12 weeks and at 24 weeks just after the treatments' end. The study's primary outcome is the glycated hemoglobin level at 24 weeks. Secondary outcomes of clinical relevance to type 2 diabetes and elderlies will also be acquired.
Read the detailed description
This study is a randomized controlled trial, three-arm parallel-group. The first aim is to evaluate the efficacy of a supervised and structured combined exercise training program in HbA1c levels at 24 weeks. Secondary outcomes measurements of clinical relevance for type 2 diabetes and elderly patients are included at 12 and 24 weeks.
The investigators will enroll 132 elderlies divided into three experimental groups, randomized in a ratio of 1:1 (44 patients per group). The treatments arms comprises structured supervised combined exercise training programs, three times a week, lasting 24 weeks of duration. The G150 group will exercise 150 min per week of aerobic and strength training (50 min per session, 25 min for each modality) and the G300 group will exercise twice the volume in the same G150's intensity, and week frequency (100 min per session, 50 min for each modality). No intervention will be offered to the control group (i.e., they will continue their usual care). Treatments arms will progress on training load tailored by their maximal heart rate percentage for aerobic training and maximal repetitions for strength training.
The sample size was calculated considering a between-group mean difference of 0.45%, with standard deviation of 0.7% in HbA1c levels, for an 80% of statistical power and 5% of type 1 error, in a superiority hypothesis design.
In detail, the primary outcome is the HbA1c level at 24 weeks, an secondary outcomes are: HbA1c levels at 12 weeks; office blood pressure assessed through a digital sphygmomanometer at 12 and 24 weeks; lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) at 24 weeks; endothelial function assessed by flow-mediated dilation at 12 and 24 weeks; intima-media thickness at 24 weeks; physical fitness assessed by maximal oxygen uptake and maximal muscle strength at 24 weeks; body composition assessed by dual x ray absorptiometry at 24 weeks; quality of life and geriatric depressive symptoms assessed by questionnaires at 24 weeks.
The investigators hypothesized that the G300 will greater improve the 24-week HbA1c levels and secondary outcomes against the G150 and the control group. The present study was designed and will be conducted by a multidisciplinary staff, and follows ethical and methodological standards for randomized clinical trials. As for empirical evidence provision, it is expected to highlight the efficacy of the non-pharmacological treatment for type 2 diabetes in the elderly patients.
- Conditions
- Type2 Diabetes
- Being tested
- G150, G300
- Keywords
- Exercise, Aging, Elderly, Physical Activity, Cardiovascular Disease
- Medical subject headings
- Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G150Behavioural
This group will receive 150 min/week of combined exercise training, structured and supervised.
G300Behavioural
This group will receive 300 min/week of combined exercise training, structured and supervised.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized to this group will perform monthly cohabitation meetings. |
| G150 | Experimental | Participants randomized to this group will be enrolled to a 150 min/week structured and supervised exercise training. The program consists of 3 sessions in a week, each of these lasting 50 minutes. The session will be composed of aerobic training (25 minutes at 60-75% of HRmax) and strength training (25 minutes, 8 whole-body exercises at up to 8-12 maximal repetitions). Receives: Behavioral: G150 |
| G300 | Experimental | Participants randomized to this group will be enrolled to the same structural settings of G150 group (type of exercise, exercise intensity and weekly frequency). They will receive twice the G150 group dose's. To do so, each session will last 100 minutes (50 minutes of aerobic exercise training and 50 minutes of strength training). Receives: Behavioral: G300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Glycated hemoglobin in DCCT units (%)
Measured: Change from baseline to 24 weeks
Secondary outcomes (14)
HbA1c
Glycated hemoglobin in DCCT units (%)
Measured: Change from baseline to 12 weeks
Office Blood Pressure
Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
Measured: Change from baseline to 12 weeks
Office Blood Pressure
Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
Measured: Change from baseline to 24 weeks
Lower limbs functional capacity
By using the Short Physical Performance Battery (SPPB), lower-limb mobility will be assess in the following sequence: static standing balance, walking speed and indirect muscle strength. The performance of functional activities will be converted to a standardized scale from 0 (poor functional capacity) to 12 points (excellent functional capacity)
Measured: Change from baseline to 24 weeks
Cardiorespiratory fitness
Peak oxygen uptake (VO2peak) assessed by maximal cardiopulmonary exercise testing and reported in its weighted form (ml/kg/min)
Measured: Change from baseline to 24 weeks
Geriatric Depression Symptoms
Geriatric depression alertness and improvements will be assessed through a questionnaire comprised by 15 questions in a YES/NO answer options nested to 0/1 numbered options. Alertness of geriatric depression is characterized when the overall score reaches 5 points or below it. The overall score is calculated a posteriori due to variations on questions directions (e.g., YES = 1 or YES = 0 conditioned to the question).
Measured: Change from baseline to 24 weeks
Endothelial function, early adaptation
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Measured: Change from baseline to 12 weeks
Endothelial function
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Measured: Change from baseline to 24 weeks
Intima-media thickness
Intima-media thickness (IMT) assessed through high resolution ultrasonography
Measured: Change from baseline to 24 weeks
Body composition
Body composition assessed by dual x-ray absorptiometry system (DXA)
Measured: Change from baseline to 24 weeks
Quality of life (QoL)
Patients' quality of life will be assessed by the World Health Organization Quality of Life for Elderlies (WHOQoL-OLD) instrument. It comprises 24 questions and answers are presented in a one-way direction, 1-to-5 scale.
Measured: Change from baseline to 24 weeks
Muscle thickness
Muscle thickness assessed through high resolution ultrasonography
Measured: Change from baseline to 24 weeks
Muscle quality
Image echo-intensity assessed through high resolution ultrasonography
Measured: Change from baseline to 24 weeks
Lower body maximal muscle strength
Lower body maximal muscle strength will be assessed by the knee extension one-maximal repetition test, reported in kilograms (kg).
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start10 Sep 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Daniel Umpierre, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do SulBeatriz Schaan, MD, PhD, Study director, Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423108
- Sponsor's protocol ID
- 17-0303
- Acronym
- EDDIE
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data HbA1c and neuromuscular function and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available. Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration at a clinical trial management system nested to the EDDIE Study's website (www.ufrgs.br/eddie), and the access will be permitted after acceptance of the EDDIE Study team's data sharing terms and policy.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03423108
- Acronym / sponsor ID
- EDDIE / 17-0303
- Conditions
- Type2 Diabetes
- Keywords
- Exercise, Aging, Elderly, Physical Activity, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 10 Sep 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 6 Feb 2018 (actual)
- 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.
One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week vs 150min/week) will be compared against usual care. The entire study length will last 24 weeks, and assessments will be conducted at baseline, previously to the group allocation, at 12 weeks and at 24 weeks just after the treatments' end. The study's primary outcome is the glycated hemoglobin level at 24 weeks. Secondary outcomes of clinical relevance to type 2 diabetes and elderlies will also be acquired.
Detailed description
This study is a randomized controlled trial, three-arm parallel-group. The first aim is to evaluate the efficacy of a supervised and structured combined exercise training program in HbA1c levels at 24 weeks. Secondary outcomes measurements of clinical relevance for type 2 diabetes and elderly patients are included at 12 and 24 weeks.
The investigators will enroll 132 elderlies divided into three experimental groups, randomized in a ratio of 1:1 (44 patients per group). The treatments arms comprises structured supervised combined exercise training programs, three times a week, lasting 24 weeks of duration. The G150 group will exercise 150 min per week of aerobic and strength training (50 min per session, 25 min for each modality) and the G300 group will exercise twice the volume in the same G150's intensity, and week frequency (100 min per session, 50 min for each modality). No intervention will be offered to the control group (i.e., they will continue their usual care). Treatments arms will progress on training load tailored by their maximal heart rate percentage for aerobic training and maximal repetitions for strength training.
The sample size was calculated considering a between-group mean difference of 0.45%, with standard deviation of 0.7% in HbA1c levels, for an 80% of statistical power and 5% of type 1 error, in a superiority hypothesis design.
In detail, the primary outcome is the HbA1c level at 24 weeks, an secondary outcomes are: HbA1c levels at 12 weeks; office blood pressure assessed through a digital sphygmomanometer at 12 and 24 weeks; lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) at 24 weeks; endothelial function assessed by flow-mediated dilation at 12 and 24 weeks; intima-media thickness at 24 weeks; physical fitness assessed by maximal oxygen uptake and maximal muscle strength at 24 weeks; body composition assessed by dual x ray absorptiometry at 24 weeks; quality of life and geriatric depressive symptoms assessed by questionnaires at 24 weeks.
The investigators hypothesized that the G300 will greater improve the 24-week HbA1c levels and secondary outcomes against the G150 and the control group. The present study was designed and will be conducted by a multidisciplinary staff, and follows ethical and methodological standards for randomized clinical trials. As for empirical evidence provision, it is expected to highlight the efficacy of the non-pharmacological treatment for type 2 diabetes in the elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to this group will perform monthly cohabitation meetings. |
| G150 | Experimental | Behavioral: G150Participants randomized to this group will be enrolled to a 150 min/week structured and supervised exercise training. The program consists of 3 sessions in a week, each of these lasting 50 minutes. The session will be composed of aerobic training (25 minutes at 60-75% of HRmax) and strength training (25 minutes, 8 whole-body exercises at up to 8-12 maximal repetitions). |
| G300 | Experimental | Behavioral: G300Participants randomized to this group will be enrolled to the same structural settings of G150 group (type of exercise, exercise intensity and weekly frequency). They will receive twice the G150 group dose's. To do so, each session will last 100 minutes (50 minutes of aerobic exercise training and 50 minutes of strength training). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous diagnosis of type 2 diabetes mellitus by HbA1c (> 6.5%) or capillary casual glycemia (> 126 mg/dL), oral glucose tolerance test or hypoglycemic drug use;
- HbA1c ≥ 7.5%;
- Verified ability to exercise;
- Physically inactive or regularly exercising for at least once a week.
Key exclusion criteria (14 listed)
- HbA1c ≤ 12%;
- Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable cardioverter defibrillator);
- Major cardiovascular events 1 year previously to the enrollment (non-fatal myocardial infarction, coronary artery bypass surgery, cardiac catheterization, deep vein thrombosis, hospitalization or other severe health-related event);
- Chronic renal disease requesting dialysis;
- Severe macular injury (retinopathy) that disables patients to enroll an exercise program;
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 |
|---|---|---|
| G150This group will receive 150 min/week of combined exercise training, structured and supervised. | Behavioural | G150 |
| G300This group will receive 300 min/week of combined exercise training, structured and supervised. | Behavioural | G300 |
Primary outcome
HbA1c
Time frame: Change from baseline to 24 weeks
Glycated hemoglobin in DCCT units (%)
14 secondary outcomes
HbA1c
Time frame: Change from baseline to 12 weeks
Office Blood Pressure
Time frame: Change from baseline to 12 weeks
Office Blood Pressure
Time frame: Change from baseline to 24 weeks
Lower limbs functional capacity
Time frame: Change from baseline to 24 weeks
Cardiorespiratory fitness
Time frame: Change from baseline to 24 weeks
Geriatric Depression Symptoms
Time frame: Change from baseline to 24 weeks
Endothelial function, early adaptation
Time frame: Change from baseline to 12 weeks
Endothelial function
Time frame: Change from baseline to 24 weeks
Intima-media thickness
Time frame: Change from baseline to 24 weeks
Body composition
Time frame: Change from baseline to 24 weeks
Quality of life (QoL)
Time frame: Change from baseline to 24 weeks
Muscle thickness
Time frame: Change from baseline to 24 weeks
Muscle quality
Time frame: Change from baseline to 24 weeks
Lower body maximal muscle strength
Time frame: Change from baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Yes. Data HbA1c and neuromuscular function and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available. Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration at a clinical trial management system nested to the EDDIE Study's website (www.ufrgs.br/eddie), and the access will be permitted after acceptance of the EDDIE Study team's data sharing terms and policy.
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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.
Daniel Umpierre, PhD principal investigator
Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul
Beatriz Schaan, MD, PhD study director
Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G150 and G300 in people with Type2 Diabetes, run by Hospital de Clinicas de Porto Alegre at 1 site in 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angélica De Nardi, MSc (+55 51 3359-6332, atnardi@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Change from baseline to 24 weeks). 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 6 Sep 2018.