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Concurrent Training and Prediabetes Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502304
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
Universidad de Los Lagos
Healthcare Center Tomas Rojas
Universidad del Rosario
Information provided by (Responsible Party):
Universidad Santo Tomas

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metabolic Disturbance Behavioral: Endurance training plus resistant training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Behavioral
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
Actual Study Start Date : June 10, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control group
No-exercise
 Behavioral: Endurance training plus resistant training
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.
Experimental: Endurance training plus resistant training
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.
 Behavioral: Endurance training plus resistant training
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.


Outcome Measures
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Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in fasting glucose

  2. Lipoproteins [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from baseline in lipoproteins


Secondary Outcome Measures :
  1. Body mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in body mass

  2. Waist circumference [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in waist circumference

  3. Fat mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in fat mass

  4. Lean mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in lean mass

  5. Heart rate at rest [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in heart rate at rest

  6. Six minutes walking test [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
    Change from Baseline in six minutes walking test


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502304


Locations
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Chile
Cristian Alvarez
Los Lagos, Osorno, Chile, 000000000
Sponsors and Collaborators
Universidad Santo Tomas
Universidad de Los Lagos
Healthcare Center Tomas Rojas
Universidad del Rosario
Investigators
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Principal Investigator: Cristian Alvarez, PhD Universidad de Los Lagos
  Study Documents (Full-Text)

Documents provided by Universidad Santo Tomas:
Study Protocol and Statistical Analysis Plan  [PDF] April 16, 2018

More Information
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Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT03502304    
Other Study ID Numbers: 9042018
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Santo Tomas:
Metabolic syndrome
Obesity
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases