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Concurrent Training and Prediabetes Control

Primary Purpose

Metabolic Disturbance

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Endurance training plus resistant training
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disturbance focused on measuring Metabolic syndrome, Obesity

Eligibility Criteria

30 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent.
  • Interested in improving health and fitness.

Exclusion Criteria:

  • Cardiovascular contraindications to exercise,
  • History of stroke, asthma or chronic obstructive pulmonary disease,
  • Muscle-skeletal disorders, and
  • Smoking.
  • A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.

Sites / Locations

  • Cristian Alvarez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Endurance training plus resistant training

Arm Description

No-exercise

To concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.

Outcomes

Primary Outcome Measures

Fasting glucose
Change from Baseline in fasting glucose
Lipoproteins
Change from baseline in lipoproteins

Secondary Outcome Measures

Body mass
Change from Baseline in body mass
Waist circumference
Change from Baseline in waist circumference
Fat mass
Change from Baseline in fat mass
Lean mass
Change from Baseline in lean mass
Heart rate at rest
Change from Baseline in heart rate at rest
Six minutes walking test
Change from Baseline in six minutes walking test

Full Information

First Posted
April 9, 2018
Last Updated
May 29, 2018
Sponsor
Universidad Santo Tomas
Collaborators
Universidad de Los Lagos, Healthcare Center Tomas Rojas, Universidad del Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT03502304
Brief Title
Concurrent Training and Prediabetes Control
Official Title
Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Universidad de Los Lagos, Healthcare Center Tomas Rojas, Universidad del Rosario

4. Oversight

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

5. Study Description

Brief Summary
Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disturbance
Keywords
Metabolic syndrome, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No-exercise
Arm Title
Endurance training plus resistant training
Arm Type
Experimental
Arm Description
To concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.
Intervention Type
Behavioral
Intervention Name(s)
Endurance training plus resistant training
Intervention Description
CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Change from Baseline in fasting glucose
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Lipoproteins
Description
Change from baseline in lipoproteins
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Body mass
Description
Change from Baseline in body mass
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Waist circumference
Description
Change from Baseline in waist circumference
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Fat mass
Description
Change from Baseline in fat mass
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Lean mass
Description
Change from Baseline in lean mass
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Heart rate at rest
Description
Change from Baseline in heart rate at rest
Time Frame
Baseline and 20-weeks immediately after the interventions ends
Title
Six minutes walking test
Description
Change from Baseline in six minutes walking test
Time Frame
Baseline and 20-weeks immediately after the interventions ends

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent. Interested in improving health and fitness. Exclusion Criteria: Cardiovascular contraindications to exercise, History of stroke, asthma or chronic obstructive pulmonary disease, Muscle-skeletal disorders, and Smoking. A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Alvarez, PhD
Organizational Affiliation
Universidad de Los Lagos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristian Alvarez
City
Los Lagos
State/Province
Osorno
ZIP/Postal Code
000000000
Country
Chile

12. IPD Sharing Statement

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Concurrent Training and Prediabetes Control

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