ClinicalTrials.gg
CompletedNCT03489083Updated Apr 5, 2018

Heat Shock Response is Blunted in Elderly Diabetic People But Recovered by Strength Training

An interventional study of Strength training and No Training in Type 2 Diabetes Mellitus and Aging, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Feb 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 313 studies in Diabetes Mellitus, Type 2 with a site in Brazil — 33 open to participants now, 41 under way, 19 of them phase 3. Diabetes Mellitus, Type 2 · Brazil.

Enrollment
249th of 292
30 · median 320
Started
2016
with 13 others
No phase
82 of 313
12 open now
Registered
215th of 313
by date

Among the 313 studies in Diabetes Mellitus, Type 2 with a site in Brazil, this one is the 249th largest by enrollment of the 292 interventional ones that give a count, is one of 14 that started in 2016, is one of 82 with no phase, and was the 215th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

33 of the 313 studies in Diabetes Mellitus, Type 2 with a site in Brazil are open now. Recruiting first, the newest first:

28 more — sign in →

All 33 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 45 Years to 85 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 313 studies in Diabetes Mellitus, Type 2 with a site in Brazil, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Type 2 Diabetes Mellitus
  • Aging

Keywords

  • Diabetes
  • Heat Shock Response
  • Aging
  • Exercise
04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • . Inclusion criteria for diabetic people were ≤ 7,5% (within the last six months), controlled blood pressure and no use of insulin.

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Trained Group

    Subjects performing strength training three times per week for twelve weeks.

    Other: Strength training

  • Placebo comparator
    No Training Group

    Subjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks.

    Other: No Training

Interventions

  • OtherStrength training

    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.

  • OtherNo Training

    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.

06

What researchers measure

Primary outcomes

  1. Heat Shock Response Change.

    Capacity of cells to express and export heat shock protein 72kDa in response to heat (ng/mL).

    Time frame: Before and After twelve weeks of exercise training.

Secondary outcomes

  1. hs-CRP Change.

    Marker of Inflammation measured in mg/L.

    Time frame: Before and After twelve weeks of exercise training.

  2. Body composition Change.

    Body mass index (in Kg/m2).

    Time frame: Before and After twelve weeks of exercise training.

  3. TNF-a Change.

    Marker of Inflammation measured in pg/mL.

    Time frame: Before and After twelve weeks of exercise training.

  4. IL-10 Change.

    Marker of Inflammation measured in pg/mL.

    Time frame: Before and After twelve weeks of exercise training.

  5. Visceral Adipose Tissue Change.

    Amount of visceral adipose tissue measured in millimeters (mm).

    Time frame: Before and After twelve weeks of exercise training.

07

Study locations

1 site
  • Universidade Federal do Rio Grande do Sul
    Porto Alegre, RS 90040-060, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — All data, including HSR, body composition, inflammatory and oxidative stress markers and metabolites.

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: After training completion

Access criteria: All volunteers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Feb 2018, 24 months.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 24 months is above that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Apr 5, 2018
StartActual
Feb 1, 2016
Primary completionActual
Feb 1, 2018
CompletionActual
Mar 1, 2018
Last update
Apr 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03489083
Responsible party
Maurício Krause (Professor, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Apr 5, 2018
Start date
Feb 1, 2016
Primary completion
Feb 1, 2018
Completion
Mar 1, 2018
Last update
Apr 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion