Concurrent Training and Prediabetes Control

• ClinicalTrials.gov Identifier: NCT03502304
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: May 31, 2018
• Sponsor: Universidad Santo Tomas
• Collaborators: Universidad de Los Lagos; Healthcare Center Tomas Rojas; Universidad del Rosario
• Information provided by (Responsible Party): Universidad Santo Tomas

Tracking Information

• First Submitted Date: April 9, 2018
• First Posted Date: April 18, 2018
• Last Update Posted Date: May 31, 2018
• Actual Study Start Date: June 10, 2017
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2018)

• Fasting glucose [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in fasting glucose
• Lipoproteins [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from baseline in lipoproteins

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2018)

• Body mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in body mass
• Waist circumference [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in waist circumference
• Fat mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in fat mass
• Lean mass [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in lean mass
• Heart rate at rest [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in heart rate at rest
• Six minutes walking test [ Time Frame: Baseline and 20-weeks immediately after the interventions ends ]
  Change from Baseline in six minutes walking test

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Concurrent Training and Prediabetes Control
• Official Title: Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Behavioral

Masking: Single (Investigator)
Primary Purpose: Prevention

• Condition: Metabolic Disturbance

Intervention

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.

Study Arms

• Active Comparator: Control group
  No-exercise
  Intervention: Behavioral: Endurance training plus resistant training
• 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.
  Intervention: Behavioral: Endurance training plus resistant training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2018): 28
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 9, 2018
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT03502304
• Other Study ID Numbers: 9042018
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Universidad Santo Tomas
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Santo Tomas
• Original Study Sponsor: Same as current

Collaborators

• Universidad de Los Lagos
• Healthcare Center Tomas Rojas
• Universidad del Rosario

Investigators

• Principal Investigator: Cristian Alvarez, PhD; Universidad de Los Lagos

• PRS Account: Universidad Santo Tomas
• Verification Date: May 2018