Clinical trial NCT01182948: Effects of Different Types of Exercise in Type 2 Diabetes
Official title: Comparison of Aerobic and Resistance Training Effects on Glycemic Control in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: aerobic training
resistance training
type 2 diabetes
therapy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in haemoglobin A1c (HbA1c) levels
timeFrame: 4 months
Secondary outcomes:
measure: Change in body weight
timeFrame: 4 months
measure: Change in body composition
timeFrame: 4 months
measure: Change in fasting plasma glucose levels
timeFrame: 4 months
measure: Change in total cholesterol levels
timeFrame: 4 months
measure: Change in HDL-cholesterol levels
timeFrame: 4 months
measure: Change in LDL-cholesterol levels
timeFrame: 4 months
measure: Change in triglycerides levels
timeFrame: 4 months
measure: Change in blood pressure
timeFrame: 4 months
measure: Change in insulin sensitivity
timeFrame: 4 months
measure: Change in energy expenditure
timeFrame: 4 months
measure: Change in antidiabetic medications
timeFrame: 4 months
measure: Compliance
timeFrame: 4 months
measure: Change in beta-cell function
timeFrame: 4 months
measure: Change in energy expenditure through voluntary physical activity
timeFrame: 4 months
measure: Change in peak oxygen uptake
timeFrame: 4 months
measure: Change in tissue oxygen extraction
timeFrame: 4 months
measure: Change in liver and muscle fat content
timeFrame: 4 months
measure: Change in blood glucose during and after exercise
timeFrame: 48 hours
measure: Muscle strength
timeFrame: 4 months
measure: Change in 6 minutes walk distance
timeFrame: 4 months
measure: Change in flexibility
timeFrame: 4 months
measure: Changes in expression in the muscle of some genes involved in ATP production, mitochondrial biogenesis and substrate utilization
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Paolo Moghetti, MD.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Olioso 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.
citation: Bellavere 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.
citation: Bacchi 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.
citation: Bacchi 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.