Type 2 DiabetesRAED2NCT01182948
Effects of Different Types of Exercise in Type 2 Diabetes
A study testing Aerobic Training and Resistance Training in people with Type 2 Diabetes, run by Universita di Verona.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Aerobic Training and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Comparison of Aerobic and Resistance Training Effects on Glycemic Control 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Aerobic Training, Resistance Training
- Keywords
- aerobic training, resistance training, type 2 diabetes, therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingBehavioural
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 TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | The aerobic training group will use cardiovascular training devices. Receives: Behavioral: Aerobic Training |
| Resistance Exercise | Experimental | The resistance training group will perform exercises on weight machines and free weights. Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemoglobin A1c (HbA1c) levels
The measurement of HbA1c is carried out with a DCCT (Diabetes Control and Complications Trial)-aligned method.
Measured: 4 months
Secondary outcomes (22)
Change in body weight
Measured: 4 months
Change in body composition
Assessment by DEXA (Dual energy X-ray absorptiometry)
Measured: 4 months
Change in fasting plasma glucose levels
Measured: 4 months
Change in total cholesterol levels
Measured: 4 months
Change in HDL-cholesterol levels
Measured: 4 months
Change in LDL-cholesterol levels
Measured: 4 months
Change in triglycerides levels
Measured: 4 months
Change in blood pressure
Measured: 4 months
Change in insulin sensitivity
Measured by euglycemic hyperinsulinemic clamp
Measured: 4 months
Change in energy expenditure
Measured by indirect calorimetry
Measured: 4 months
Change in antidiabetic medications
Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol.
Measured: 4 months
Compliance
Attendance at the scheduled sessions is recorded for each patient.
Measured: 4 months
Change in beta-cell function
Measured by OGTT (Oral Glucose Tolerance Test)
Measured: 4 months
Change in energy expenditure through voluntary physical activity
Energy expenditure is estimated through metabolic Holter (Sense Wear Armband) and IPAQ (International physical activity questionnaire).
Measured: 4 months
Change in peak oxygen uptake
Measured during an incremental exercise test
Measured: 4 months
Change in tissue oxygen extraction
Measured by NIRS (Near-infrared spectroscopy) during an incremental test exercise
Measured: 4 months
Change in liver and muscle fat content
Measured by Magnetic Resonance Imaging
Measured: 4 months
Change in blood glucose during and after exercise
Measured by continuous glucose monitoring system
Measured: 48 hours
Muscle strength
Measured by 1RM (one-repetition maximum) test
Measured: 4 months
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.
Measured: 4 months
Change in flexibility
Measured by "sit and reach" test and "back scratch" test
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Moghetti, Universita di Verona
- Investigators
- Paolo Moghetti, MD.,Ph.D., Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182948
- Sponsor's protocol ID
- CE1578
- Acronym
- RAED2
- Status last verified
- Aug 2011
- First submitted
- 16 Aug 2010
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dauriz M, Olioso D, Moghetti P. Response to Comment on Olioso D, et al. "Effect of Aerobic and Resistance Training on Circulating Micro-RNA Expression Profile in Subjects with Type 2 Diabetes". J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa068. doi: 10.1210/clinem/dgaa068. No abstract available.
PubMed 32080720Olioso D, Dauriz M, Bacchi E, Negri C, Santi L, Bonora E, Moghetti P. Effects of Aerobic and Resistance Training on Circulating Micro-RNA Expression Profile in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1119-1130. doi: 10.1210/jc.2018-01820.
PubMed 30445461Bellavere F, Cacciatori V, Bacchi E, Gemma ML, Raimondo D, Negri C, Thomaseth K, Muggeo M, Bonora E, Moghetti P. Effects of aerobic or resistance exercise training on cardiovascular autonomic function of subjects with type 2 diabetes: A pilot study. Nutr Metab Cardiovasc Dis. 2018 Mar;28(3):226-233. doi: 10.1016/j.numecd.2017.12.008. Epub 2018 Jan 2.
PubMed 29402509Bacchi E, Negri C, Trombetta M, Zanolin ME, Lanza M, Bonora E, Moghetti P. Differences in the acute effects of aerobic and resistance exercise in subjects with type 2 diabetes: results from the RAED2 Randomized Trial. PLoS One. 2012;7(12):e49937. doi: 10.1371/journal.pone.0049937. Epub 2012 Dec 5.
PubMed 23227155Bacchi E, Negri C, Zanolin ME, Milanese C, Faccioli N, Trombetta M, Zoppini G, Cevese A, Bonadonna RC, Schena F, Bonora E, Lanza M, Moghetti P. Metabolic effects of aerobic training and resistance training in type 2 diabetic subjects: a randomized controlled trial (the RAED2 study). Diabetes Care. 2012 Apr;35(4):676-82. doi: 10.2337/dc11-1655. Epub 2012 Feb 16.
PubMed 22344613
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic and Resistance Training Effects on Glycemic Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01182948
- Acronym / sponsor ID
- RAED2 / CE1578
- Conditions
- Type 2 Diabetes
- Keywords
- aerobic training, resistance training, type 2 diabetes, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic TrainingThe aerobic training group will use cardiovascular training devices. |
| Resistance Exercise | Experimental | Behavioral: Resistance TrainingThe resistance training group will perform exercises on weight machines and free weights. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic TrainingThe 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. | Behavioural | Aerobic Exercise |
| Resistance TrainingThe 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. | Behavioural | Resistance Exercise |
Primary outcome
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.
22 secondary outcomes
Change in body weight
Time frame: 4 months
Change in body composition
Time frame: 4 months
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
Change in energy expenditure
Time frame: 4 months
Change in antidiabetic medications
Time frame: 4 months
Compliance
Time frame: 4 months
Change in beta-cell function
Time frame: 4 months
Change in energy expenditure through voluntary physical activity
Time frame: 4 months
Change in peak oxygen uptake
Time frame: 4 months
Change in tissue oxygen extraction
Time frame: 4 months
Change in liver and muscle fat content
Time frame: 4 months
Change in blood glucose during and after exercise
Time frame: 48 hours
Muscle strength
Time frame: 4 months
Change in 6 minutes walk distance
Time frame: 4 months
Change in flexibility
Time frame: 4 months
Changes in expression in the muscle of some genes involved in ATP production, mitochondrial biogenesis and substrate utilization
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
- Derived from this study: PubMed 32080720Dauriz M, Olioso D, Moghetti P. Response to Comment on Olioso D, et al. "Effect of Aerobic and Resistance Training on Circulating Micro-RNA Expression Profile in Subjects with Type 2 Diabetes". J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa068. doi: 10.1210/clinem/dgaa068. No abstract available.
- Derived from this study: PubMed 30445461Olioso D, Dauriz M, Bacchi E, Negri C, Santi L, Bonora E, Moghetti P. Effects of Aerobic and Resistance Training on Circulating Micro-RNA Expression Profile in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1119-1130. doi: 10.1210/jc.2018-01820.
- Derived from this study: PubMed 29402509Bellavere F, Cacciatori V, Bacchi E, Gemma ML, Raimondo D, Negri C, Thomaseth K, Muggeo M, Bonora E, Moghetti P. Effects of aerobic or resistance exercise training on cardiovascular autonomic function of subjects with type 2 diabetes: A pilot study. Nutr Metab Cardiovasc Dis. 2018 Mar;28(3):226-233. doi: 10.1016/j.numecd.2017.12.008. Epub 2018 Jan 2.
- Derived from this study: PubMed 23227155Bacchi E, Negri C, Trombetta M, Zanolin ME, Lanza M, Bonora E, Moghetti P. Differences in the acute effects of aerobic and resistance exercise in subjects with type 2 diabetes: results from the RAED2 Randomized Trial. PLoS One. 2012;7(12):e49937. doi: 10.1371/journal.pone.0049937. Epub 2012 Dec 5.
- Derived from this study: PubMed 22344613Bacchi E, Negri C, Zanolin ME, Milanese C, Faccioli N, Trombetta M, Zoppini G, Cevese A, Bonadonna RC, Schena F, Bonora E, Lanza M, Moghetti P. Metabolic effects of aerobic training and resistance training in type 2 diabetic subjects: a randomized controlled trial (the RAED2 study). Diabetes Care. 2012 Apr;35(4):676-82. doi: 10.2337/dc11-1655. Epub 2012 Feb 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Moghetti, MD.,Ph.D. principal investigator
Universita di Verona
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training and Resistance Training in people with Type 2 Diabetes, run by Universita di Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in haemoglobin A1c (HbA1c) levels (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182948, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2011.