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Concurrent Training in Type 2 Diabetes (CONTRADIA)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
RE only
RE + HIIT
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Concurrent training, Type 2 Diabetes Mellitus, Resistance exercise, High-Intensity Interval Training (HIIT), Muscle hypertrophy, Interference effect

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male sex
  • White British/European
  • Aged between 40 and 65 years at the time of screening
  • Have a body mass index (BMI; body weight/height in m2) between 27 and 40 kg/m2
  • Sedentary/untrained for at least 1 year (based on physical activity self-reports of fewer than two sessions of structured exercise per week last <30 min)
  • T2DM (American Diabetes Association 2014) for more than 1 year
  • Central obesity (defined as waist circumference ≥94 cm for males)

Exclusion Criteria:

  • Currently involved in research or have recently (<6 months) been involved in any research prior to recruitment
  • Any condition limiting or contraindicating physical activity; including diabetic peripheral neuropathy, and coronary or peripheral artery disease
  • Previous myocardial infarction, previous or current angina, shortness of breath, or other symptoms suggestive of heart failure
  • Insulin medication
  • HbA1c more than 75 mmol/mol (9%)
  • Uncontrollable hypertension: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg
  • Not weight stable for the last three months
  • Smokers (within the last 12 months)
  • Anticoagulant medication, such as warfarin or newer anticoagulant drugs. If participants are on aspirin medication, this would need to be stopped for 3 days prior to and during the day of any biopsy visit unless contraindicated (in which case participants would be excluded).

Sites / Locations

  • School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

RE training only

Concurrent RE + HIIT

Arm Description

RE only - Progressive resistance exercise training only (leg extension, leg step up, chest press and pull down).

RE + HIIT - Progressive resistance exercise training (leg extension, leg step up, chest press and pull down) followed by HIIT (10 x 1 min at 90% heart rate maximum).

Outcomes

Primary Outcome Measures

Change in fibre-type specific satellite cell content
Assessed using immunofluorescence microscopy (Pax7-positive cells)

Secondary Outcome Measures

Change in muscle-specific gene expression related to growth adaptations
Assessed using reverse-transcription polymerase chain reactions
Change in muscle fibre size
Assessed using immunofluorescence microscopy techniques to determine muscle fibre type-specific cross-sectional area
Change in muscle size
Assessed using MRI to determine whole and individual muscle group cross-section area and total muscle volume
Change in isometric muscle strength
Assessed using a dynamometer
Change in isokinetic muscle strength
Assessed using a dynamometer
Change in cardiorespiratory fitness
Assessed using a V̇O2 peak test on a cycle ergometer
Change in habitual physical activity levels
Assessed using 7-day continuous accelerometry data
Change in exercise enjoyment
Assessed using validated questionnaires (PACES)
Change in glycaemic control
Assessed using blood analysis

Full Information

First Posted
September 4, 2017
Last Updated
July 13, 2018
Sponsor
University of Birmingham
Collaborators
Loughborough University, Metabolic Fitness Association, Italy, Università degli studi di Roma Foro Italico
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1. Study Identification

Unique Protocol Identification Number
NCT03278704
Brief Title
Concurrent Training in Type 2 Diabetes
Acronym
CONTRADIA
Official Title
Effects of Concurrent Resistance Exercise and High-intensity Interval Exercise Training on Skeletal Muscle Adaptations in Individuals With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment goal not met in allotted recruitment period
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
Loughborough University, Metabolic Fitness Association, Italy, Università degli studi di Roma Foro Italico

4. Oversight

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

5. Study Description

Brief Summary
It is recommended that individuals perform a combination of resistance exercise (RE) and endurance exercise. Lack of time is often cited as a reason for being unable to meet current exercise guidelines. Therefore, combining both forms in one session may be beneficial. However, research continues to elucidate whether interference of adaptive outcomes occurs when RE and endurance exercise are performed concurrently. A proposed interference effect suggests that concurrent training may dampen RE-induced adaptations (e.g., muscle strength and growth) compared to RE only. The propose of this investigation is to determine the effects of concurrent RE and high-intensity interval training (HIIT), compared to RE only, on muscle health and cardiovascular risk in sedentary, middle-aged (40-65 years) who are overweight/obese with type 2 diabetes mellitus (T2DM). The investigators will measure the effects on muscle strength, muscle growth, cardiovascular fitness, glycaemic control and markers of cardiovascular risk before and after an 8-week training program. Data will be obtained through the analysis of skeletal muscle samples, blood samples, magnetic resonance imaging, questionnaires and exercise performance tests.It is hypothesized that concurrent RE + HIIT will amplify the exercise-induced muscle growth response, which will result in greater satellite cell content, compared to RE alone. As a result, this will lead to greater skeletal muscle mass and strength after RE + HIIT compared to RE in isolation. A finding that concurrent resistance training and HIIT does not impede muscle adaptations could offer future strategies to minimize exercise time commitment whilst still maximizing the physiological benefits of both resistance and endurance exercise through a single training session. This may therefore provide an effective exercise strategy in the prevention and/or treatment of T2DM.
Detailed Description
Data analysis will be performed using IBM SPSS statistical software (IBM Corp., Armonk, New York, USA). All data will be checked for normality and appropriate log transformations applied prior to analysis of variance (ANOVA) for primary and secondary outcomes. Satellite cell content will be compared using a two-way, mixed-model ANOVA with one within (2 levels; pre- and post-training) and one between factor (2 level; exercise group) with significance set at P < 0.05. Based on a mixed ANOVA with between- and within-participant factors, and previously published data (Babcock et al. 2012), a sample size of 24 participants (12 per group) will provide a power of 84%. This sample size will allow detection of a mean change in satellite cell content of 2.35, assuming standard deviations of the change from pre- to post-training as 2.266 and 1.331 in the two exercise groups. Sample size calculation was performed with an alpha error of 0.05. SamplePower 2.0 (SPSS Inc., Chicago, Illinois, USA) software was used to determine sample size. This study will combine data collected at the University of Birmingham with previously collected data from an identical study design performed by a co-investigator (Dr Pugh) in Rome, Italy. The previous study has collected data from 10 participants across both exercise groups (RE, N = 7; RE + HIIT, N = 3). Therefore, it is necessary for the present study to recruit a further 14 participants (RE, N = 5, RE + HIIT, N = 9) in order to achieve a sample size of 24 participants (12 per group). However, based on an assumption of a 25% drop-out rate, the total minimal sample necessary will be 19 participants (RE, N = 7; RE + HIIT, N = 12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Concurrent training, Type 2 Diabetes Mellitus, Resistance exercise, High-Intensity Interval Training (HIIT), Muscle hypertrophy, Interference effect

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an exploratory randomized controlled trial. Participants will complete a parallel designed study, in which they will be randomly assigned to a resistance exercise (RE) only or concurrent RE and high-intensity interval training (RE + HIIT) group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RE training only
Arm Type
Other
Arm Description
RE only - Progressive resistance exercise training only (leg extension, leg step up, chest press and pull down).
Arm Title
Concurrent RE + HIIT
Arm Type
Experimental
Arm Description
RE + HIIT - Progressive resistance exercise training (leg extension, leg step up, chest press and pull down) followed by HIIT (10 x 1 min at 90% heart rate maximum).
Intervention Type
Other
Intervention Name(s)
RE only
Intervention Description
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise.
Intervention Type
Other
Intervention Name(s)
RE + HIIT
Intervention Description
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. Concurrent training: RE followed by HIIT within the same session.
Primary Outcome Measure Information:
Title
Change in fibre-type specific satellite cell content
Description
Assessed using immunofluorescence microscopy (Pax7-positive cells)
Time Frame
Prior to the 8-week training intervention and 72 hours after the last training session
Secondary Outcome Measure Information:
Title
Change in muscle-specific gene expression related to growth adaptations
Description
Assessed using reverse-transcription polymerase chain reactions
Time Frame
Prior to the 8-week training intervention and 72 hours after the last training session
Title
Change in muscle fibre size
Description
Assessed using immunofluorescence microscopy techniques to determine muscle fibre type-specific cross-sectional area
Time Frame
Prior to the 8-week training intervention and 72 hours after the last training session
Title
Change in muscle size
Description
Assessed using MRI to determine whole and individual muscle group cross-section area and total muscle volume
Time Frame
Prior to the 8-week training intervention and 48 hours after the last training session
Title
Change in isometric muscle strength
Description
Assessed using a dynamometer
Time Frame
Prior to the 8-week training intervention and 6 days after the last training session
Title
Change in isokinetic muscle strength
Description
Assessed using a dynamometer
Time Frame
Prior to the 8-week training intervention and 6 days after the last training session
Title
Change in cardiorespiratory fitness
Description
Assessed using a V̇O2 peak test on a cycle ergometer
Time Frame
Prior to the 8-week training intervention and 6 days after the last training session
Title
Change in habitual physical activity levels
Description
Assessed using 7-day continuous accelerometry data
Time Frame
Prior to the 8-week training intervention and 1 week after the last training session
Title
Change in exercise enjoyment
Description
Assessed using validated questionnaires (PACES)
Time Frame
After the first and last training session
Title
Change in glycaemic control
Description
Assessed using blood analysis
Time Frame
Prior to the 8-week training intervention and 72 hours after the last training session

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male sex White British/European Aged between 40 and 65 years at the time of screening Have a body mass index (BMI; body weight/height in m2) between 27 and 40 kg/m2 Sedentary/untrained for at least 1 year (based on physical activity self-reports of fewer than two sessions of structured exercise per week last <30 min) T2DM (American Diabetes Association 2014) for more than 1 year Central obesity (defined as waist circumference ≥94 cm for males) Exclusion Criteria: Currently involved in research or have recently (<6 months) been involved in any research prior to recruitment Any condition limiting or contraindicating physical activity; including diabetic peripheral neuropathy, and coronary or peripheral artery disease Previous myocardial infarction, previous or current angina, shortness of breath, or other symptoms suggestive of heart failure Insulin medication HbA1c more than 75 mmol/mol (9%) Uncontrollable hypertension: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg Not weight stable for the last three months Smokers (within the last 12 months) Anticoagulant medication, such as warfarin or newer anticoagulant drugs. If participants are on aspirin medication, this would need to be stopped for 3 days prior to and during the day of any biopsy visit unless contraindicated (in which case participants would be excluded).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor M Nimmo, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24357209
Citation
American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.
Results Reference
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PubMed Identifier
22492813
Citation
Babcock L, Escano M, D'Lugos A, Todd K, Murach K, Luden N. Concurrent aerobic exercise interferes with the satellite cell response to acute resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Jun 15;302(12):R1458-65. doi: 10.1152/ajpregu.00035.2012. Epub 2012 Apr 4.
Results Reference
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Concurrent Training in Type 2 Diabetes

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