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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00917930
Other study ID # 090505
Secondary ID
Status Completed
Phase Phase 4
First received June 2, 2009
Last updated June 10, 2009
Start date January 2006
Est. completion date January 2007

Study information

Verified date June 2009
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients admitted to undergo a cycle of in-hospital cardiac rehabilitation

- patients without a previous diagnosis of diabetes mellitus

- patients able to start physical training within three days from admission

- fasting blood glucose at admission < 126 mg/dl

Exclusion Criteria:

- previous diagnosis of diabetes mellitus

- acute coronary events or acute heart failure in the past three months

- physical disabilities that contraindicate training

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Behavioral:
physical training
intensive cardiac rehabilitation program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome

Type Measure Description Time frame Safety issue
Primary to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus
Secondary to evaluate the potential beneficial effect of physical training on the glycometabolic state
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