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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Moghetti, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01182948
First received: August 16, 2010
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Aerobic Training
Behavioral: Resistance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Aerobic and Resistance Training Effects on Glycemic Control in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Change in haemoglobin A1c (HbA1c) levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The measurement of HbA1c is carried out with a DCCT (Diabetes Control and Complications Trial)-aligned method.


Secondary Outcome Measures:
  • Change in body weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessment by DEXA (Dual energy X-ray absorptiometry)

  • Change in fasting plasma glucose levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in total cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in HDL-cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in LDL-cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in triglycerides levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by euglycemic hyperinsulinemic clamp

  • Change in energy expenditure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by indirect calorimetry

  • Change in antidiabetic medications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol.

  • Compliance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Attendance at the scheduled sessions is recorded for each patient.

  • Change in beta-cell function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by OGTT (Oral Glucose Tolerance Test)

  • Change in energy expenditure through voluntary physical activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured during an incremental exercise test

  • Change in tissue oxygen extraction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by NIRS (Near-infrared spectroscopy) during an incremental test exercise

  • Change in liver and muscle fat content [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by Magnetic Resonance Imaging

  • Change in blood glucose during and after exercise [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Measured by continuous glucose monitoring system

  • Muscle strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by 1RM (one-repetition maximum) test

  • Change in 6 minutes walk distance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    mRNA analysis with multiplex tandem real-time PCR of fine needle aspirates obtained from the vastus lateralis muscle


Enrollment: 40
Study Start Date: January 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exercise
The aerobic training group will use cardiovascular training devices.
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.
Experimental: Resistance Exercise
The resistance training group will perform exercises on weight machines and free weights.
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182948

Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Paolo Moghetti, MD.,Ph.D. Universita di Verona
  More Information

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Moghetti, Associate Professor of Endocrinology, Universita di Verona
ClinicalTrials.gov Identifier: NCT01182948     History of Changes
Other Study ID Numbers: CE1578
Study First Received: August 16, 2010
Last Updated: August 24, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
aerobic training
resistance training
type 2 diabetes
therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014