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

NCT ID: NCT01899872

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Patients with type 1 diabetes

Patients with type 1 diabetes

Group Type EXPERIMENTAL

Resistance exercise session

Intervention Type BEHAVIORAL

Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.

Aerobic exercise session

Intervention Type BEHAVIORAL

Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.

Interventions

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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.

Intervention Type BEHAVIORAL

Aerobic exercise session

Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Beatriz D'Agord Schaan

Beatriz D'Agord Schaan

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Beatriz D'Agord Schaan, Phd

Role: CONTACT

51-33598127

Gustavo Waclawovsky, Masters student

Role: CONTACT

51-33596332

Facility Contacts

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Gustavo Waclawovsky, Masters

Role: primary

51-33596332

Other Identifiers

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100400

Identifier Type: -

Identifier Source: org_study_id

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