Normal Serum Adiponectin Levels in Females

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by The Cooper Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT00454623
First received: March 29, 2007
Last updated: March 30, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: drawing serum adiponectin level

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Normal Serum Adiponectin Levels in Females During the Childbearing Ages and Normal Serum Adiponectin Levels in Pregnancy

Resource links provided by NLM:


Further study details as provided by The Cooper Health System:

Estimated Enrollment: 300
Study Start Date: March 2006
Estimated Study Completion Date: June 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 15 - 40 years old.
  2. BMI: 18.5 - 24.9
  3. No medical or chronic health problems.
  4. If pregnant, singleton.
  5. First blood sample can be obtained before 13 weeks gestation.
  6. Plans to continue pregnancy till term and deliver at our hospital

Exclusion Criteria:

  1. Hypertension.
  2. Diabetes Mellitus.
  3. Ischemic heart disease.
  4. Metabolic disorders e.g. hyperlipidemia, hypercholesterolemia.
  5. Endocrinological diseases e.g. thyroid or adrenal diseases.
  6. Chronic Debilitating diseases e.g. SLE, or Cancer.
  7. BMI less than18.5 or greater than 25.
  8. Anorexia or Bulimia.
  9. Polycystic ovarian disease.
  10. In pregnant group:

    1. Multiple gestations.
    2. Hyperemesis or dehydration.
    3. History of Gestational Diabetes, Preeclampsia, or other complications with previous pregnancies
    4. If abnormal weight gain during pregnancy, will continue in the study but would not be included in establishing normal levels.
  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: NCT00454623

Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: Hazem Elshoreya, MD The Cooper Health System
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00454623     History of Changes
Other Study ID Numbers: 06041EX
Study First Received: March 29, 2007
Last Updated: March 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The Cooper Health System:
Adiponectin
diabetes
metabolism
Adiponectin levels

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

ClinicalTrials.gov processed this record on October 16, 2014