Cardiorespiratory Performance in Diabetic Elderly

NCT ID: NCT01757080

Last Updated: 2012-12-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of 40 elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50 ±5.85 years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The significance level was set at p\<0.05.

Detailed Description

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Conditions

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Diabetics Patients Hypertensive Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Diabetic-hypertensive elderly

Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test

Group Type EXPERIMENTAL

Cardiorespiratory performance assessment with ergospirometry test

Intervention Type OTHER

Biochemical analysis

Intervention Type OTHER

Hypertensive elderly

Biochemical analysis and Cardiorespiratory performance assessment with ergospirometry test

Group Type ACTIVE_COMPARATOR

Cardiorespiratory performance assessment with ergospirometry test

Intervention Type OTHER

Biochemical analysis

Intervention Type OTHER

Interventions

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Cardiorespiratory performance assessment with ergospirometry test

Intervention Type OTHER

Biochemical analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60-years-old or above
* diagnosis of hypertension and/or T2DM for at least 2 years
* member active of the hypertension and diabetes mellitus program
* be on optimized drug therapy for more than 3 months
* BMI above 22 kg/m²;
* no heart disease
* non-insulin-dependent,
* sedentary according to the International Physical Activity Questionnaire (IPAQ) and
* functionally independent.

Exclusion Criteria

* ergospirometry interrupted by adaptive,
* hemodynamic, and electrocardiographic complications;
* respiratory exchange ratio (R) lower than 1.0 at the end of exertion,
* VE/VCO2 value higher than 34 in the first anaerobic threshold;
* chronic atrial fibrillation;
* neuromuscular,
* orthopedic,
* peripheral vascular,
* pulmonary diseases;
* myocardial infarction within 6 months;
* orthopedic limitation or musculoskeletal pain.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Daniella Cunha Brandao

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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Kathiresan S, Otvos JD, Sullivan LM, Keyes MJ, Schaefer EJ, Wilson PW, D'Agostino RB, Vasan RS, Robins SJ. Increased small low-density lipoprotein particle number: a prominent feature of the metabolic syndrome in the Framingham Heart Study. Circulation. 2006 Jan 3;113(1):20-9. doi: 10.1161/CIRCULATIONAHA.105.567107. Epub 2005 Dec 27.

Reference Type RESULT
PMID: 16380547 (View on PubMed)

Hollenberg M, Yang J, Haight TJ, Tager IB. Longitudinal changes in aerobic capacity: implications for concepts of aging. J Gerontol A Biol Sci Med Sci. 2006 Aug;61(8):851-8. doi: 10.1093/gerona/61.8.851.

Reference Type RESULT
PMID: 16912104 (View on PubMed)

Other Identifiers

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etiene

Identifier Type: -

Identifier Source: org_study_id