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Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated Type 2 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Xijing Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372852
First Posted: June 14, 2011
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Xijing Hospital
  Purpose
The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.

Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated T2DM Patients in Chinese Population

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • plasma adiponectin concentration, isoform distribution and activity. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week ]

Biospecimen Retention:   Samples Without DNA
blood,abdominal fat tissue

Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
T2DM patients
newly diagnosed T2DM patients and untreated with any drugs.
Non-diabetic Control Group

Detailed Description:
Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulfide-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This study enrolls a group of 30-70years patients from primary care clinic who have diabetes history within 12 months and without taking any treatment.
Criteria

Inclusion Criteria:

  • Having a diabetic history within 12 months
  • BMI smaller than 30kg/m2

Exclusion Criteria:

  • Having any kinds of treatment affecting glucose
  • pregnant
  • uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372852


Contacts
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, MD,PhD    +86-15002955798    lingtao2006@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Ling Tao, M.D Ph.D Department of Cardiology of Xijing Hospital, Fourth Military Medical University
  More Information

Responsible Party: Ling Tao, Department of Cardiology of Xijing Hospital; Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01372852     History of Changes
Other Study ID Numbers: xjyy110501
First Submitted: June 11, 2011
First Posted: June 14, 2011
Last Update Posted: June 14, 2011
Last Verified: May 2010

Keywords provided by Xijing Hospital:
Diabetes mellitus

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