Normal Serum Adiponectin Levels in Females
Recruitment status was Active, not recruiting
|First Received Date ICMJE||March 29, 2007|
|Last Updated Date||March 30, 2007|
|Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00454623 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Normal Serum Adiponectin Levels in Females|
|Official Title ICMJE||Normal Serum Adiponectin Levels in Females During the Childbearing Ages and Normal Serum Adiponectin Levels in Pregnancy|
The purpose of the study is to establish the normal levels of the hormone adiponectin in women. Adiponectin is a newly discovered hormone, which is said to be associated with many changes in the human body and metabolism. The researchers aim is to establish the normal levels of this hormone. Hence, the researchers can identify people with abnormal levels who may be at risk of diseases and can do more studies to help them.
The prevalence of obesity has increased dramatically in recent years . It is commonly associated with type 2 diabetes, coronary artery disease, and hypertension, and the coexistence of these diseases has been termed the metabolic syndrome. White Adipose Tissue (WAT) has been increasingly recognized as an important endocrine organ that secretes a number of biologically active “adipokines” . Of these adipokines, adiponectin has recently attracted much attention because of its antidiabetic and antiatherogenic effects and is expected to be a novel therapeutic tool for diabetes and the metabolic syndrome . Adiponectin directly regulates glucose metabolism and insulin sensitivity by activation of AMPK.
Adiponectin expression is reduced in obese, insulin-resistant rodent models. Plasma adiponectin levels are also decreased in an obese rhesus monkey model that frequently develops type 2 diabetes. Levels have also been reported to be reduced in obese humans, particularly those with visceral obesity, and to correlate inversely with insulin resistance. Prospective and longitudinal studies have shown that lower adiponectin levels are associated with a higher incidence of diabetes.
Hypoadiponectinemia has been demonstrated to be independently associated with the metabolic syndrome. Reduced plasma adiponectin levels are also commonly observed in a variety of states frequently associated with insulin resistance, such as cardiovascular disease, ischemic heart disease, and hypertension. In women, lower adiponectin levels were associated with breast cancer, endometrial cancer, and polycystic ovarian syndrome.
By establishing normal serum levels of Adiponectin, researchers will be able to demonstrate deviations from the norm associated with investigated diseases and variables. When applied to pregnancy, it will help identify obstetrical complications associated with abnormal levels.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Condition ICMJE||Diabetes Mellitus|
|Intervention ICMJE||Behavioral: drawing serum adiponectin level|
|Study Arm (s)||Not Provided|
|Publications *||Cseh K, Baranyi E, Melczer Z, Kaszas E, Palik E, Winkler G. Plasma adiponectin and pregnancy-induced insulin resistance. Diabetes Care. 2004 Jan;27(1):274-5. No abstract available.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||15 Years to 40 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00454623|
|Other Study ID Numbers ICMJE||06041EX|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The Cooper Health System|
|Collaborators ICMJE||Not Provided|
|Information Provided By||The Cooper Health System|
|Verification Date||March 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP