Type 2 Diabetes MellitusNCT03489083
Heat Shock Response is Blunted in Elderly Diabetic People But Recovered by Strength Training
A study testing Strength training and No Training in people with Type 2 Diabetes Mellitus and Aging, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults, healthy elderly adults and type 2 diabetic elderly people. In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Aging
- What is being tested?
- Strength training and No Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2016to 1 Mar 2018
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . Inclusion criteria for diabetic people were HbA1c ≤ 7,5% (within the last six months), controlled blood pressure and no use of insulin.
Who cannot join
- Participants were excluded if they reported a history of myocardial infarction, cardiac illness, vascular disease, stroke, major systemic disease or any condition that would prevent them from engaging in an exercise study; or if they were already engaging in two or more planned and structured exercise sessions per week (in the last six months).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90040-060
About this study
Official title: Heat-induced Extracellular HSP72 Release is Blunted in Elderly Diabetic People in Comparison With Healthy Middle-aged and Older Adults But is Partially Restored by Strength Training
The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults, healthy elderly adults and type 2 diabetic elderly people. In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic elderly people. Thirty (19 females and 11 males) sedentary non-smoking participants volunteered for this study (11 healthy middle-age adults, 7 healthy old adults and 12 diabetic old subjects, previously diagnosed by their personal physicians).
Firstly, venous blood samples were obtained from all participants to test the HSR. They were divided in three groups: healthy middle-age adults (45-59 y.o.), healthy elderly adults and elderly diabetic (> 60 y.o.). As we identify that diabetic people presented a poor HSR, we submit the diabetic group to a twelve-week resistance exercise training to verify if this intervention could improve the HS response.
Read more
Diabetic subjects were randomly (1:1 block randomization) allocated in one of the two groups: Trained and Control (no training). Strength training was performed three times per week while the control group performed a "placebo" stretching/relaxing session once a week (for adherence purposes). Both interventions had twelve weeks of duration. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort.
Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. Exercises included leg press, knee extensions and leg curls, biceps curls, triceps extensions, lat pull-downs, shoulder press, bench press and abdominal crunch. Before the start of the training period, subjects completed a familiarization session to practice the exercises they would further perform during the training sessions, where the exercise load was individually tested. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
- Conditions
- Type 2 Diabetes Mellitus, Aging
- Being tested
- Strength training, No Training
- Keywords
- Diabetes, Heat Shock Response, Aging, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Strength training was performed three times per week for twelve weeks. Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
No TrainingOther
Control group performed a "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Trained Group | Experimental | Subjects performing strength training three times per week for twelve weeks. Receives: Other: Strength training |
| No Training Group | Placebo comparator | Subjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks. Receives: Other: No Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat Shock Response Change.
Capacity of cells to express and export heat shock protein 72kDa in response to heat (ng/mL).
Measured: Before and After twelve weeks of exercise training.
Secondary outcomes (5)
hs-CRP Change.
Marker of Inflammation measured in mg/L.
Measured: Before and After twelve weeks of exercise training.
Body composition Change.
Body mass index (in Kg/m2).
Measured: Before and After twelve weeks of exercise training.
TNF-a Change.
Marker of Inflammation measured in pg/mL.
Measured: Before and After twelve weeks of exercise training.
IL-10 Change.
Marker of Inflammation measured in pg/mL.
Measured: Before and After twelve weeks of exercise training.
Visceral Adipose Tissue Change.
Amount of visceral adipose tissue measured in millimeters (mm).
Measured: Before and After twelve weeks of exercise training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Feb 2016
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults (45-59 years old), healthy elderly adults (\> 60 y.o.) and type 2 diabetic elderly people (\> 60 y.o.). In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic elderly people.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurício Krause, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489083
- Sponsor's protocol ID
- UFRGS 1.614.907
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data, including HSR, body composition, inflammatory and oxidative stress markers and metabolites.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat-induced Extracellular HSP72 Release is Blunted in Elderly Diabetic People in Comparison With Healthy Middle-aged and Older Adults But is Partially Restored by Strength Training
- ClinicalTrials.gov ID
- NCT03489083
- Acronym / sponsor ID
- UFRGS 1.614.907
- Conditions
- Type 2 Diabetes Mellitus, Aging
- Keywords
- Diabetes, Heat Shock Response, Aging, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 5 Apr 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.
The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults, healthy elderly adults and type 2 diabetic elderly people. In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic elderly people. Thirty (19 females and 11 males) sedentary non-smoking participants volunteered for this study (11 healthy middle-age adults, 7 healthy old adults and 12 diabetic old subjects, previously diagnosed by their personal physicians).
Firstly, venous blood samples were obtained from all participants to test the HSR. They were divided in three groups: healthy middle-age adults (45-59 y.o.), healthy elderly adults and elderly diabetic (> 60 y.o.). As we identify that diabetic people presented a poor HSR, we submit the diabetic group to a twelve-week resistance exercise training to verify if this intervention could improve the HS response.
Diabetic subjects were randomly (1:1 block randomization) allocated in one of the two groups: Trained and Control (no training). Strength training was performed three times per week while the control group performed a "placebo" stretching/relaxing session once a week (for adherence purposes). Both interventions had twelve weeks of duration. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort.
Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. Exercises included leg press, knee extensions and leg curls, biceps curls, triceps extensions, lat pull-downs, shoulder press, bench press and abdominal crunch. Before the start of the training period, subjects completed a familiarization session to practice the exercises they would further perform during the training sessions, where the exercise load was individually tested. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aim of this study was to compare the heat shock response (HSR) between healthy middle-aged adults (45-59 years old), healthy elderly adults (> 60 y.o.) and type 2 diabetic elderly people (> 60 y.o.). In addition, considering the effects of strength exercise in promoting health, we aimed to test the effects of strength training over the HSR in diabetic elderly people.
| Arm | Type | Receives |
|---|---|---|
| Trained Group | Experimental | Other: Strength trainingSubjects performing strength training three times per week for twelve weeks. |
| No Training Group | Placebo comparator | Other: No TrainingSubjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . Inclusion criteria for diabetic people were HbA1c ≤ 7,5% (within the last six months), controlled blood pressure and no use of insulin.
Key exclusion criteria (1 listed)
- Participants were excluded if they reported a history of myocardial infarction, cardiac illness, vascular disease, stroke, major systemic disease or any condition that would prevent them from engaging in an exercise study; or if they were already engaging in two or more planned and structured exercise sessions per week (in the last six months).
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 |
|---|---|---|
| Strength trainingStrength training was performed three times per week for twelve weeks. Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM. | Other | Trained Group |
| No TrainingControl group performed a "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort. | Other | No Training Group |
Primary outcome
Heat Shock Response Change.
Time frame: Before and After twelve weeks of exercise training.
Capacity of cells to express and export heat shock protein 72kDa in response to heat (ng/mL).
5 secondary outcomes
hs-CRP Change.
Time frame: Before and After twelve weeks of exercise training.
Body composition Change.
Time frame: Before and After twelve weeks of exercise training.
TNF-a Change.
Time frame: Before and After twelve weeks of exercise training.
IL-10 Change.
Time frame: Before and After twelve weeks of exercise training.
Visceral Adipose Tissue Change.
Time frame: Before and After twelve weeks of exercise training.
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 5 Apr 2018.
- Individual participant dataSharing planned: Yes. All data, including HSR, body composition, inflammatory and oxidative stress markers and metabolites.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and No Training in people with Type 2 Diabetes Mellitus and Aging, run by Federal University of Rio Grande do Sul 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 1 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: finished, as of the sponsor's last update on 5 Apr 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. Some participants in this study may receive a placebo. 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?
Heat Shock Response Change. (time frame: Before and After twelve weeks of exercise training.). 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 5 Apr 2018.