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Completed

NCT Number: NCT01182948

Effects of Different Types of Exercise in Type 2 Diabetes

The purposes of this study are: a) to compare the effects of supervised programs of aerobic training or resistance training on the metabolic control of type 2 diabetes; b) to investigate some potential pathophysiologic and molecular mechanisms underlying these effects; c) to assess whether some changes may persist over time after termination of the supervised programs.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Meta-analyses of studies which evaluated the effects of interventions based upon structured exercise programs in patients with type 2 diabetes show that regular physical activity may improve glycosylated haemoglobin (HbA1c) by 0.6-0.7%. Most studies assessed the effects of aerobic exercise. However, recent data suggest that resistance training may result in similar effects. It seems likely that these beneficial results are obtained through different molecular mechanisms by aerobic training and resistance training. Consequently, these exercise modalities could be synergistic in improving the metabolic abnormalities in these subjects. On the other hand, comparison data are very limited.

Aims of the protocol are to compare the effects of aerobic training or resistance training on the metabolic control of type 2 diabetes and to investigate some potential pathophysiologic and molecular mechanisms underlying these effects.

The study will be carried out in 40 sedentary type 2 diabetic patients without diabetic complications, aged 40-70 yr, with body mass index (BMI) between 24-36 kg/m2 and HbA1c between 6.5-9.0%. Admitted diabetes treatments will be diet and oral hypoglycemic agents.

Subjects will be assigned, by a randomization schedule weighted by baseline BMI and fitness, to 2 groups of supervised exercise: aerobic training or resistance training. Training programs will have a similar volume and will be scheduled in three 60 min sessions per week for 4 months. During the study subjects will be instructed to follow an isocaloric diet. Before and at the end of the exercise training the following will be assessed: HbA1c (primary outcome), plasma glucose, lipid profile, blood pressure, insulin sensitivity (glucose clamp), body composition (Dual energy X-ray absorptiometry, DEXA), liver and muscle fat content (magnetic resonance imaging), expression in the muscle of some genes involved in ATP production, mitochondrial biogenesis and substrate utilization, markers of inflammation, oxidative stress and early vascular damage, peak oxygen uptake (VO2peak) during a maximal exercise test, other exercise tests, tissue oxygen extraction during exercise (Near-infrared spectroscopy, NIRS), energy expenditure and physical activity in daily life (metabolic Holter and questionnaire). Monitoring of blood glucose will also be carried out over a 48h period, comprising an exercise session (Continuous Glucose Monitoring System).

Metabolic features, exercise tests, body composition, daily physical activity and expression of relevant genes in the muscle will also be assessed 1 yr after completion of the training programs, to establish whether some changes may persist over time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI between 24-36 kg/m2;
  • HbA1c between 6.5-9.0%;
  • diabetes diagnosis must have been made at least 1 yr previously;
  • admitted diabetes treatments will be diet and oral hypoglycemic agents;
  • baseline physical activity, estimated by the IPAQ questionnaire, lower than 1000 MET min per week;
  • baseline body weight stable (changes lower than 2 kg in the last 2 months).

Exclusion criteria

  • moderate-severe somatic or autonomic neuropathy;
  • coronary heart disease;
  • peripheral or cerebral vascular disease;
  • preproliferative or proliferative retinopathy or chronic renal failure (serum creatinine >1.4 mg/dl in females; >1.5 mg/dl in males);
  • therapy with beta-blocker drugs;
  • smokers;
  • acute clinically significant intercurrent diseases;
  • inability to perform the scheduled physical activity programs.

Treatment and study plan

Aerobic training

Behavioral

The aerobic training group will exercise on cardiovascular training equipment. The workload will be gradually increased up to 60% of the reserve heart rate. Subjects will exercise 3 times per week for 60 min in the Fitness Centre of the Exercise and Sport Science School. Training will be carried out in small groups, under the supervision of personal trainers. During the study subjects will be instructed to follow an isocaloric diet.

Resistance training

Behavioral

The resistance training group will perform different exercises on weight machines and free weights to exercise upper and lower extremity muscles. Participants will perform 8-10 different exercises each session, alternating abdominal, upper and lower extremity exercises. Subjects will exercise 3 times per week for 60 min in the Fitness Centre of the Exercise and Sport Science School. Training will be carried out in small groups, under the supervision of personal trainers. During the study subjects will be instructed to follow an isocaloric diet.

Primary outcomes

  1. Change in haemoglobin A1c (HbA1c) levels

    Time frame: 4 months

    The measurement of HbA1c is carried out with a DCCT (Diabetes Control and Complications Trial)-aligned method.

Secondary outcomes

  1. Change in body weight

    Time frame: 4 months

  2. Change in body composition

    Time frame: 4 months

    Assessment by DEXA (Dual energy X-ray absorptiometry)

  3. Change in fasting plasma glucose levels

    Time frame: 4 months

  4. Change in total cholesterol levels

    Time frame: 4 months

  5. Change in HDL-cholesterol levels

    Time frame: 4 months

  6. Change in LDL-cholesterol levels

    Time frame: 4 months

  7. Change in triglycerides levels

    Time frame: 4 months

  8. Change in blood pressure

    Time frame: 4 months

  9. Change in insulin sensitivity

    Time frame: 4 months

    Measured by euglycemic hyperinsulinemic clamp

  10. Change in energy expenditure

    Time frame: 4 months

    Measured by indirect calorimetry

  11. Change in antidiabetic medications

    Time frame: 4 months

    Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol.

  12. Compliance

    Time frame: 4 months

    Attendance at the scheduled sessions is recorded for each patient.

  13. Change in beta-cell function

    Time frame: 4 months

    Measured by OGTT (Oral Glucose Tolerance Test)

  14. Change in energy expenditure through voluntary physical activity

    Time frame: 4 months

    Energy expenditure is estimated through metabolic Holter (Sense Wear Armband) and IPAQ (International physical activity questionnaire).

  15. Change in peak oxygen uptake

    Time frame: 4 months

    Measured during an incremental exercise test

  16. Change in tissue oxygen extraction

    Time frame: 4 months

    Measured by NIRS (Near-infrared spectroscopy) during an incremental test exercise

  17. Change in liver and muscle fat content

    Time frame: 4 months

    Measured by Magnetic Resonance Imaging

  18. Change in blood glucose during and after exercise

    Time frame: 48 hours

    Measured by continuous glucose monitoring system

  19. Muscle strength

    Time frame: 4 months

    Measured by 1RM (one-repetition maximum) test

  20. Change in 6 minutes walk distance

    Time frame: 4 months

    This test measures the number of meters that can be walked in 6 minutes over a 30 m course. It is a simple field test to assess aerobic functional capacity.

  21. Change in flexibility

    Time frame: 4 months

    Measured by "sit and reach" test and "back scratch" test

  22. Changes in expression in the muscle of some genes involved in ATP production, mitochondrial biogenesis and substrate utilization

    Time frame: 4 months

    mRNA analysis with multiplex tandem real-time PCR of fine needle aspirates obtained from the vastus lateralis muscle

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Comparison of Aerobic and Resistance Training Effects on Glycemic Control in Type 2 Diabetes

Acronym: RAED2

Important dates

Study start
2009
Primary completion
2010
First posted
Aug 17, 2010
Registry last updated
Aug 25, 2011

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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