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

Primary Purpose

Type 2 Diabetes Mellitus, Aging

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strength training
No Training
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Heat Shock Response, Aging, Exercise

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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).

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trained Group

No Training Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hs-CRP Change.
Marker of Inflammation measured in mg/L.
Body composition Change.
Body mass index (in Kg/m2).
TNF-a Change.
Marker of Inflammation measured in pg/mL.
IL-10 Change.
Marker of Inflammation measured in pg/mL.
Visceral Adipose Tissue Change.
Amount of visceral adipose tissue measured in millimeters (mm).

Full Information

First Posted
March 20, 2018
Last Updated
March 28, 2018
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03489083
Brief Title
Heat Shock Response is Blunted in Elderly Diabetic People But Recovered by Strength Training
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Aging
Keywords
Diabetes, Heat Shock Response, Aging, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trained Group
Arm Type
Experimental
Arm Description
Subjects performing strength training three times per week for twelve weeks.
Arm Title
No Training Group
Arm Type
Placebo Comparator
Arm Description
Subjects performing "placebo" stretching/relaxing session once a week (for adherence purposes) for twelve weeks.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heat Shock Response Change.
Description
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 Outcome Measure Information:
Title
hs-CRP Change.
Description
Marker of Inflammation measured in mg/L.
Time Frame
Before and After twelve weeks of exercise training.
Title
Body composition Change.
Description
Body mass index (in Kg/m2).
Time Frame
Before and After twelve weeks of exercise training.
Title
TNF-a Change.
Description
Marker of Inflammation measured in pg/mL.
Time Frame
Before and After twelve weeks of exercise training.
Title
IL-10 Change.
Description
Marker of Inflammation measured in pg/mL.
Time Frame
Before and After twelve weeks of exercise training.
Title
Visceral Adipose Tissue Change.
Description
Amount of visceral adipose tissue measured in millimeters (mm).
Time Frame
Before and After twelve weeks of exercise training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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).
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90040-060
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data, including HSR, body composition, inflammatory and oxidative stress markers and metabolites.
IPD Sharing Time Frame
After training completion
IPD Sharing Access Criteria
All volunteers

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

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