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
  Purpose

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.


Condition
Irisin
Endothelial Dysfunction
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • The relation between plasma irisin and endothelium-dependent vasodilation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
type 2 diabetes
We select 200 newly diagnosed type 2 diabetic patients. Plasma irisin levels will be measured, and endothelial function will be determined.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877603

Contacts
Contact: Xiang Guangda, MD +8602768878410 Guangda64@hotmail.com

Locations
China, Hubei
Wuhan General Hospital Not yet recruiting
Wuhan, Hubei, China, 430070
Contact: Lu Junyan, MD    +8602768878411    buyuelingyun@outlook.com   
Wuhan General Hospital Recruiting
Wuhan, Hubei, China, 430070
Contact: Xiang Guangda, MD    +8602768879059    Guangda64@hotmail.com   
Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
  More Information

No publications provided

Responsible Party: Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01877603     History of Changes
Other Study ID Numbers: 2013Wze030
Study First Received: June 11, 2013
Last Updated: September 8, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014