NCT01182948

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

August 16, 2010

Last Update Submit

August 24, 2011

Conditions

Keywords

aerobic trainingresistance trainingtype 2 diabetestherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (22)

  • Change in body weight

    4 months

  • Change in body composition

    4 months

  • Change in fasting plasma glucose levels

    4 months

  • Change in total cholesterol levels

    4 months

  • Change in HDL-cholesterol levels

    4 months

  • +17 more secondary outcomes

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

The aerobic training group will use cardiovascular training devices.

Behavioral: Aerobic Training

Resistance Exercise

EXPERIMENTAL

The resistance training group will perform exercises on weight machines and free weights.

Behavioral: Resistance Training

Interventions

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.

Aerobic Exercise

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.

Resistance Exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paolo Moghetti, MD.,Ph.D.

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Endocrinology

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Last Updated

August 25, 2011

Record last verified: 2011-08