Concurrent Training in Type 2 Diabetes

NCT03278704 | Terminated

• 3 other identifiers: RG_16-218ERN_16-1612RRK6071
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Concurrent training; Type 2 Diabetes Mellitus; Resistance exercise; High-Intensity Interval Training (HIIT); Muscle hypertrophy; Interference effect

Outcome Measures

Primary Outcomes (1)

• Change in fibre-type specific satellite cell content

  Assessed using immunofluorescence microscopy (Pax7-positive cells)

  Prior to the 8-week training intervention and 72 hours after the last training session

Secondary Outcomes (9)

• Change in muscle-specific gene expression related to growth adaptations

  Prior to the 8-week training intervention and 72 hours after the last training session

• Change in muscle fibre size

  Prior to the 8-week training intervention and 72 hours after the last training session

• Change in muscle size

  Prior to the 8-week training intervention and 48 hours after the last training session

• Change in isometric muscle strength

  Prior to the 8-week training intervention and 6 days after the last training session

• Change in isokinetic muscle strength

  Prior to the 8-week training intervention and 6 days after the last training session

Study Arms (2)

RE training only

OTHER

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

Other: RE only

Concurrent RE + HIIT

EXPERIMENTAL

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).

Other: RE + HIIT

Interventions

RE only OTHER

8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise.

RE training only

RE + HIIT OTHER

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.

Concurrent RE + HIIT

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Birmingham: lead
• Loughborough University: collaborator
• Metabolic Fitness Association, Italy: collaborator
• Università degli studi di Roma Foro Italico: collaborator

Study Sites (1)

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

Birmingham, B15 2TT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24357209 BACKGROUND

• 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.

  PMID: 22492813 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Professor M Nimmo, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 12, 2017
• Study Start: December 6, 2017
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

GB (1)