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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01877603
Other study ID # 2013Wze030
Secondary ID
Status Completed
Phase N/A
First received June 11, 2013
Last updated June 12, 2015
Start date July 2013
Est. completion date December 2013

Study information

Verified date June 2015
Source Wuhan General Hospital of Guangzhou Military Command
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

Irisin is a signaling protein that is released into the blood from skeletal muscle after proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin activity on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1 expression and induction of brown adipocytes in white adipose tissue depots, a process known as white fat ''browning''. Irisin increases total energy expenditure in animal models, and irisin expression in mice fed a high fat diet resulted in a significant improvement in glucose tolerance and a reduction in fasting insulin levels. Collectively, these data suggest that decreased serum irisin levels may be associated with the development of insulin resistance and Type 2 diabetes. Indeed, some studies showed that irisin levels were decreased in newly diagnosed Type 2 diabetes.

Endothelial dysfunction is an early physiological event in atherosclerosis. However, to date, no data are available on the relationship between circulating irisin and endothelial dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin level is associated with endothelial dysfunction.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- newly diagnosed type 2 diabetic patients

- aged 40~70 years

Exclusion Criteria:

- Patients with hypertension and those with micro- and macroangiopathy, including nephropathy [urinary albumin excretion rate (UAER) > 20 µg/min], retinopathy (at least one microaneurysm or hemorrhage or exudates in either eye), neuropathy (pain in extremities, paresthesias, and absent tendon re?exes and/or absent vibration sense), coronary artery disease (myocardial infarction, ischemia electrocardiogram changes, and angina), cerebrovascular disease (transient ischemic attack or stroke), and peripheral vascular disease (the abolition of one or more peripheral arterial pulse and/or intermittent claudication and/or a past history of revascularization of the lower limbs) were excluded from the study.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
China Wuhan General Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The relation between plasma irisin and endothelium-dependent vasodilation 6 months Yes
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