Pituitary Derived-Intermedin is an Estrogen-Modulated Factor for Reducing Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00133783
First received: August 23, 2005
Last updated: October 25, 2005
Last verified: May 2005
  Purpose

Calcitonin, calcitonin gene-related peptides (CGRPs), adrenomedullin, and amylin belong to a unique group of peptide hormones important for the regulation of calcium balance, neurotransmission, cardiovascular homeostasis, and glucose metabolism. We, the investigators at Chang Gung Memorial Hospital, recently identified intermedin as a novel peptide hormone belonging to this unique peptide ligand family. Adrenomedullin is a 52-amino-acid peptide and is one of the most potent vasodilators. Plasma adrenomedullin is elevated in a variety of pathological conditions such as hypertension, renal failure, heart failure, and septic shock. CGRPα and CGRPβ are 37-amino acid neuropeptides; primarily release from sensory nerves; and play important roles in regulating peripheral vascular tone and controlling blood flow in various organs. Human mature intermedin encodes 40-amino-acid and is expressed mainly in the adrenocorticotrophs of the anterior and intermediate pituitary lobe. Intermedin signals through calcitonin receptor-like receptor (CRLR)/receptor activity-modifying protein (RAMP) receptor complexes, and CRLR/RAMP signaling has been proven to be critical for vascular tone regulation. Based on this finding, we had documented that intraperitoneal administration of intermedin dose-dependently suppressed blood pressure in normal Sprague-Dawley rats. In addition, our preliminary in vitro and in vivo studies demonstrated that ovariectomy lead to a tenfold reduction of intermedin transcript expression in the pituitary in rats whereas subsequent estrogen treatment increased pituitary intermedin expression to a level similar to that of intact rats. Taken together, we propose that pituitary-derived intermedin is regulated by estrogen and exhibits potent hypotensive effects. To address this hypothesis, in Specific Aim 1, we will investigate the regulation of secretion and expression of intermedin in vitro and in vivo using cultured pituitary cells and oophorectomized rats. In Specific Aim 2, we will study the molecular mechanism by which estrogen stimulates intermedin gene expression. In Specific Aim 3, to demonstrate that the estrogen-dependent regulation of intermedin represents a critical link in the regulation of blood pressure in women, we will study the relationship between blood pressure and blood intermedin levels using a cross-sectional study. Our studies will provide a better understanding of the mechanisms by which sex hormones modulate blood pressure and open a new window for postmenopausal hypertension treatment.


Condition Intervention
Menopause
Hypertension
Behavioral: intermedin

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Intermedin is an Estrogen- Modulated Factor for Reducing Blood Pressure

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 500
Study Start Date: May 2005
Estimated Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenopausal women: no reported change in menstrual cycle pattern
  • Early peri-menopausal women: reported change in menstrual cycle frequency in preceding year with a bleed in the preceding 3 months
  • Late peri-menopausal women: no menses in the preceding 3-11 months
  • Postmenopausal women: no menses in the preceding 12 months
  • Patients who received oophorectomy
  • Patients who received hysterectomy for benign uterus tumor
  • Patients underwent assisted reproductive technology (ART).

Exclusion Criteria:

  • Patients underwent chemotherapy or radiotherapy in past two years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00133783

Contacts
Contact: Chailin Chang, M.D. 886-968372657 amego@cgmh.org.tw

Locations
Taiwan
Chailin Chang Recruiting
Kwei-Shan, Tao-Yuan, Taiwan, 333
Contact: Chialin Chang, M.D.    886-968372657    amego@cgmh.org.tw   
Principal Investigator: Chialin Chang, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chialin Chang, M.D. Chang Gung Memorial Hospital, Department of OB/GYN, 5. Fu-Hsing St. Kwei-Shan, Tao-Yuan, Taiwan, ROC
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00133783     History of Changes
Other Study ID Numbers: NMRPG34
Study First Received: August 23, 2005
Last Updated: October 25, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Intermedin
estradiol
female hypertension
Premenopausal and postmenopausal women
Surgically-induced menopause women
IVF treatment patients

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014