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Trial record 11 of 2791 for:    Type 1 Diabetes

Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes. (EAEEFD)

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ClinicalTrials.gov Identifier: NCT01899872
Recruitment Status : Unknown
Verified July 2013 by Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 16, 2013
Last Update Posted : July 16, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to evaluate the effect of a single session of aerobic plus resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The investigators hypothesize that a single aerobic exercise session would promote greater benefit in vascular function of patients with type 1 diabetes, as compared with the resistive exercise session.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Behavioral: Resistance exercise session Behavioral: Aerobic exercise session

Detailed Description:

The aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (T1DM). For this purpose, the sample size will consist of 15 patients with DM1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. Ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. Similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session.

The endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (EPC) counting. To analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating EPC. The endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of VO2 max. The resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1RM, in four exercises for lower limbs. The research will be performed at the Exercise Pathophysiology Research Laboratory of the Hospital de Clinicas de Porto Alegre. The investigators expect to find greater increase in the number of circulating EPC after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. Likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. Considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with DM1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Acute Effects of Aerobic and Resistance Exercise on Endothelial Function in Patients With Type 1 Diabetes.
Study Start Date : December 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Patients with type 1 diabetes
Patients with type 1 diabetes
Behavioral: Resistance exercise session
Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.
Behavioral: Aerobic exercise session
Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.

Outcome Measures

Primary Outcome Measures :
  1. Circulating endothelial progenitor cells [ Time Frame: 10 minutes before the exercise session and 10 minutes after the exercise session. ]
    A 20-ml sodium heparin tube will be used and peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll-Hypaque. Blood samples will be diluted with PBS and layered onto Ficoll-Hypaque in 15-ml tubes. Tubes will be centrifuged at 400 g for 30 min and the PBMC at the interface will be collected. Cells will be washed with RPMI 1640 medium and thereafter stained with 5 µl of anti-CD45-FITC , 8 µl of anti-KDR-Alexa Fluor 647, and 5 µl of anti-CD34-PE (all essays from BD, Biosciences, USA). Thereafter, 50 µl of resuspended cells will be incubated (30 min), and subsequently, 500 µl of PBS will be added for acquisition. A FACS Calibur flow cytometer will be used with Quest software (BD Biosciences, USA) equipped with 22 mW argon laser tuned at 488 nm, with a total number counted cells of 200,000 on mononuclear cells gate per sample. Percentage of CD34 positive cells will be calculated based on the number of leukocytes .

Secondary Outcome Measures :
  1. Forearm vascular reactivity [ Time Frame: 10 minutes before the exercise session and 10 minutes after the exercise session. ]

    Forearm blood flow and reactive hyperemia:

    Forearm blood flow will be measured by venous occlusion plethysmography (D.E Hokanson, USA) at the nondominant forearm. A rapid inflator cuff will be used in the upper arm to occlude venous outflow (50-60 mmHg), and three blood flow recordings will be made each minute during 3 minutes. Thereafter, reactive hyperemia will be measure using an occlusion at 250 mmHg for 5 min, which will be released by 10 seconds intervals for 2 minutes. Reactive hyperemia will be calculated using the peak blood flow after the 5 minutes the occlusion.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes
  • Male gender
  • 18-45 years old

Exclusion Criteria:

  • Severe autonomic neuropathy
  • Diabetic nephropathy established
  • Chronic kidney failure
  • Limb amputation
  • Disabling peripheral arterial disease
  • Coronary artery disease
  • Heart failure
  • Diabetic proliferative retinopathy
  • Neoplasms
  • Smokers
  • Regular physical training
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899872

Contact: Beatriz D'Agord Schaan, Phd 51-33598127 beatrizschaan@gmail.com
Contact: Gustavo Waclawovsky, Masters student 51-33596332 gwsaude@yahoo.com.br

Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Contact: Gustavo Waclawovsky, Masters    51-33596332    gwsaude@yahoo.com.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
More Information

Responsible Party: Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01899872     History of Changes
Other Study ID Numbers: 100400
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre:
Type 1 Diabetes Mellitus
Endothelial progenitor cell
Endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases