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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Endothelial Dysfunction; Irisin

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Wuhan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
type 2 diabetes; We select 200 newly diagnosed type 2 diabetic patients. Plasma irisin levels will be measured, and endothelial function will be determined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The relation between plasma irisin and endothelium-dependent vasodilation	6 months

Collaborators and Investigators

• Sponsor: Wuhan General Hospital of Guangzhou Military Command

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2013Wze030