NCT00454623

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 2, 2007

Status Verified

March 1, 2007

First QC Date

March 29, 2007

Last Update Submit

March 30, 2007

Conditions

Diabetes Mellitus

Keywords

AdiponectindiabetesmetabolismAdiponectin levels

Interventions

drawing serum adiponectin levelBEHAVIORAL

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Hypertension.
  • Diabetes Mellitus.
  • Ischemic heart disease.
  • Metabolic disorders e.g. hyperlipidemia, hypercholesterolemia.
  • Endocrinological diseases e.g. thyroid or adrenal diseases.
  • Chronic Debilitating diseases e.g. SLE, or Cancer.
  • BMI less than18.5 or greater than 25.
  • Anorexia or Bulimia.
  • Polycystic ovarian disease.
  • In pregnant group:
  • Multiple gestations.
  • Hyperemesis or dehydration.
  • History of Gestational Diabetes, Preeclampsia, or other complications with previous pregnancies
  • If abnormal weight gain during pregnancy, will continue in the study but would not be included in establishing normal levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (1)

  • 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. doi: 10.2337/diacare.27.1.274. No abstract available.

    PMID: 14694004BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hazem Elshoreya, MD

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 2, 2007

Study Start

March 1, 2006

Study Completion

June 1, 2007

Last Updated

April 2, 2007

Record last verified: 2007-03

Locations

US(1)