Concurrent Training and Prediabetes Control

Metabolic Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502304
• Other study ID #: 9042018
• Status: Completed
• Phase: N/A
• Start date: June 10, 2017
• Est. completion date: April 9, 2018

Study information

• Verified date: May 2018
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Disturbance
• Prediabetic State

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.

Locations

Country	Name	City	State
Chile	Cristian Alvarez	Los Lagos	Osorno

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Healthcare Center Tomas Rojas, Universidad de Los Lagos, Universidad del Rosario

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Change from Baseline in fasting glucose	Baseline and 20-weeks immediately after the interventions ends
Primary	Lipoproteins	Change from baseline in lipoproteins	Baseline and 20-weeks immediately after the interventions ends
Secondary	Body mass	Change from Baseline in body mass	Baseline and 20-weeks immediately after the interventions ends
Secondary	Waist circumference	Change from Baseline in waist circumference	Baseline and 20-weeks immediately after the interventions ends
Secondary	Fat mass	Change from Baseline in fat mass	Baseline and 20-weeks immediately after the interventions ends
Secondary	Lean mass	Change from Baseline in lean mass	Baseline and 20-weeks immediately after the interventions ends
Secondary	Heart rate at rest	Change from Baseline in heart rate at rest	Baseline and 20-weeks immediately after the interventions ends
Secondary	Six minutes walking test	Change from Baseline in six minutes walking test	Baseline and 20-weeks immediately after the interventions ends