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Effects of Different Types of Exercise in Type 2 Diabetes (RAED2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01182948
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : August 25, 2011
Sponsor:
Information provided by (Responsible Party):
Paolo Moghetti, Universita di Verona

Tracking Information
First Submitted Date  ICMJE August 16, 2010
First Posted Date  ICMJE August 17, 2010
Last Update Posted Date August 25, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2010)
Change in haemoglobin A1c (HbA1c) levels [ Time Frame: 4 months ]
The measurement of HbA1c is carried out with a DCCT-aligned method.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Change in body weight [ Time Frame: 4 months ]
  • Change in body composition [ Time Frame: 4 months ]
    Assessment by DEXA (Dual energy X-ray absorptiometry)
  • Change in fasting plasma glucose levels [ Time Frame: 4 months ]
  • Change in total cholesterol levels [ Time Frame: 4 months ]
  • Change in HDL-cholesterol levels [ Time Frame: 4 months ]
  • Change in LDL-cholesterol levels [ Time Frame: 4 months ]
  • Change in triglycerides levels [ Time Frame: 4 months ]
  • Change in blood pressure [ Time Frame: 4 months ]
  • Change in insulin sensitivity [ Time Frame: 4 months ]
    Measured by euglycemic hyperinsulinemic clamp
  • Change in energy expenditure [ Time Frame: 4 months ]
    Measured by indirect calorimetry
  • 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.
  • Compliance [ Time Frame: 4 months ]
    Attendance at the scheduled sessions is recorded for each patient.
  • Change in beta-cell function [ Time Frame: 4 months ]
    Measured by OGTT (Oral Glucose Tolerance Test)
  • 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).
  • Change in peak oxygen uptake [ Time Frame: 4 months ]
    Measured during an incremental exercise test
  • Change in tissue oxygen extraction [ Time Frame: 4 months ]
    Measured by NIRS (Near-infrared spectroscopy) during an incremental test exercise
  • Change in liver and muscle fat content [ Time Frame: 4 months ]
    Measured by Magnetic Resonance Imaging
  • Change in blood glucose during and after exercise [ Time Frame: 48 hours ]
    Measured by continuous glucose monitoring system
  • Muscle strength [ Time Frame: 4 months ]
    Measured by 1RM (one-repetition maximum) test
  • 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.
  • Change in flexibility [ Time Frame: 4 months ]
    Measured by "sit and reach" test and "back scratch" test
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2010)
  • Change in body weight [ Time Frame: 4 months ]
  • Change in body composition [ Time Frame: 4 months ]
    Assessment by DEXA
  • Change in fasting plasma glucose levels [ Time Frame: 4 months ]
  • Change in total cholesterol levels [ Time Frame: 4 months ]
  • Change in HDL-cholesterol levels [ Time Frame: 4 months ]
  • Change in LDL-cholesterol levels [ Time Frame: 4 months ]
  • Change in triglycerides levels [ Time Frame: 4 months ]
  • Change in blood pressure [ Time Frame: 4 months ]
  • Change in insulin sensitivity [ Time Frame: 4 months ]
    Measured by euglycemic hyperinsulinemic clamp
  • Change in energy expenditure [ Time Frame: 4 months ]
    Measured by indirect calorimetry
  • 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.
  • Compliance [ Time Frame: 4 months ]
    Attendance at the scheduled sessions is recorded for each patient.
  • Change in beta-cell function [ Time Frame: 4 months ]
    Measured by OGTT
  • Change in energy expenditure through voluntary physical activity [ Time Frame: 4 months ]
    Energy expenditure is estimated through metabolic Holter (Sense Wear Armband) and IPAQ questionnaire.
  • Change in peak oxygen uptake [ Time Frame: 4 months ]
    Measured during an incremental exercise test
  • Change in tissue oxygen extraction [ Time Frame: 4 months ]
    Measured by NIRS (Near infra-red spectroscopy)during an incremental test exercise
  • Change in liver and muscle fat content [ Time Frame: 4 months ]
    Measured by Magnetic Resonance Imaging
  • Change in blood glucose during and after exercise [ Time Frame: 48 hours ]
    Measured by continuous glucose monitoring system
  • Muscle strength [ Time Frame: 4 months ]
    Measured by 1RM test
  • 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.
  • Change in flexibility [ Time Frame: 4 months ]
    Measured by "sit and reach" test and "back scratch" test
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Different Types of Exercise in Type 2 Diabetes
Official Title  ICMJE Comparison of Aerobic and Resistance Training Effects on Glycemic Control in Type 2 Diabetes
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Behavioral: Aerobic Training
    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.
  • Behavioral: Resistance Training
    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.
Study Arms  ICMJE
  • Experimental: Aerobic Exercise
    The aerobic training group will use cardiovascular training devices.
    Intervention: Behavioral: Aerobic Training
  • Experimental: Resistance Exercise
    The resistance training group will perform exercises on weight machines and free weights.
    Intervention: Behavioral: Resistance Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2010)
40
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01182948
Other Study ID Numbers  ICMJE CE1578
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paolo Moghetti, Universita di Verona
Study Sponsor  ICMJE Universita di Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Moghetti, MD.,Ph.D. Universita di Verona
PRS Account Universita di Verona
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP