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

NCT ID: NCT01877603

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irisin Endothelial Dysfunction Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

type 2 diabetes

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiang Guang-da

Director of Endocrinol Dept.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wuhan General Hospital

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013Wze030

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.