Type 2 Diabetes Clinical Trial
Official title:
The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes
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 |
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.
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. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
China | Wuhan General Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wuhan General Hospital of Guangzhou Military Command |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relation between plasma irisin and endothelium-dependent vasodilation | 6 months | Yes |
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