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OpenTrials
Completed

NCT Number: NCT03502304

Concurrent Training and Prediabetes Control

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).

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Key information

Conditions

Metabolic Disturbance Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cristian Alvarez

Los Lagos, Osorno, 000000000, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endurance training plus resistant training

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas

Other

Collaborators

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

Registry information

Official study title

Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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