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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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Aging

Keywords

  • Diabetes
  • Heat Shock Response
  • Aging
  • Exercise
03

Who can participate

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

Inclusion criteria

  • . Inclusion criteria for diabetic people were HbA1c ≤ 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).
04

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.

05

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.

06

Study locations

1 site
  • Universidade Federal do Rio Grande do Sul
    Porto Alegre, RS 90040-060, Brazil
07

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, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03489083
Lead sponsor
Federal University of Rio Grande do Sul
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
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