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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01877603
First received: June 11, 2013
Last updated: September 8, 2013
Last verified: June 2013

June 11, 2013
September 8, 2013
July 2013
December 2013   (final data collection date for primary outcome measure)
The relation between plasma irisin and endothelium-dependent vasodilation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01877603 on ClinicalTrials.gov Archive Site
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The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes
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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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

From July 2013 to Dec 2013, a total of 200 Chinese Han newly diagnosed type 2 diabetic patients were selected. They had been referred to our hospital and were aged 40~70 years.

During the same period, 50 healthy subjects (all from medical staff in our hospital) were selected as control subjects.

  • Irisin
  • Endothelial Dysfunction
  • Type 2 Diabetes
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type 2 diabetes
We select 200 newly diagnosed type 2 diabetic patients. Plasma irisin levels will be measured, and endothelial function will be determined.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years to 70 Years
Yes
Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com
China
 
NCT01877603
2013Wze030
Yes
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Wuhan General Hospital of Guangzhou Military Command
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Wuhan General Hospital of Guangzhou Military Command
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP