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OpenTrials
Completed

NCT Number: NCT01877603

The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 reflexes 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.

Treatment and study plan

Primary outcomes

  1. The relation between plasma irisin and endothelium-dependent vasodilation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wuhan General Hospital of Guangzhou Military Command

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2013
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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