Effects of Different Types of Exercise in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— RAED2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182948
• Other study ID #: CE1578
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: August 24, 2011
• Start date: January 2009

Study information

• Verified date: August 2011
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in haemoglobin A1c (HbA1c) levels	The measurement of HbA1c is carried out with a DCCT (Diabetes Control and Complications Trial)-aligned method.	4 months	No
Secondary	Change in body weight		4 months	No
Secondary	Change in body composition	Assessment by DEXA (Dual energy X-ray absorptiometry)	4 months	No
Secondary	Change in fasting plasma glucose levels		4 months	No
Secondary	Change in total cholesterol levels		4 months	No
Secondary	Change in HDL-cholesterol levels		4 months	No
Secondary	Change in LDL-cholesterol levels		4 months	No
Secondary	Change in triglycerides levels		4 months	No
Secondary	Change in blood pressure		4 months	No
Secondary	Change in insulin sensitivity	Measured by euglycemic hyperinsulinemic clamp	4 months	No
Secondary	Change in energy expenditure	Measured by indirect calorimetry	4 months	No
Secondary	Change in antidiabetic medications	Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol.	4 months	No
Secondary	Compliance	Attendance at the scheduled sessions is recorded for each patient.	4 months	No
Secondary	Change in beta-cell function	Measured by OGTT (Oral Glucose Tolerance Test)	4 months	No
Secondary	Change in energy expenditure through voluntary physical activity	Energy expenditure is estimated through metabolic Holter (Sense Wear Armband) and IPAQ (International physical activity questionnaire).	4 months	No
Secondary	Change in peak oxygen uptake	Measured during an incremental exercise test	4 months	No
Secondary	Change in tissue oxygen extraction	Measured by NIRS (Near-infrared spectroscopy) during an incremental test exercise	4 months	No
Secondary	Change in liver and muscle fat content	Measured by Magnetic Resonance Imaging	4 months	No
Secondary	Change in blood glucose during and after exercise	Measured by continuous glucose monitoring system	48 hours	No
Secondary	Muscle strength	Measured by 1RM (one-repetition maximum) test	4 months	No
Secondary	Change in 6 minutes walk distance	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.	4 months	No
Secondary	Change in flexibility	Measured by "sit and reach" test and "back scratch" test	4 months	No
Secondary	Changes in expression in the muscle of some genes involved in ATP production, mitochondrial biogenesis and substrate utilization	mRNA analysis with multiplex tandem real-time PCR of fine needle aspirates obtained from the vastus lateralis muscle	4 months	Yes