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Sponsored by: |
University of Aarhus |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00825617 |
Several studies have demonstrated that Turner Syndrome patients have elevated liver enzymes readily suppressible by a short course of HRT. We wanted to estimated quantitative liver functions in a young group of Turner syndrome patients compared to a healthy control group.
Condition | Intervention |
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Turner Syndrome |
Drug: Hormone replacement therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Official Title: | Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy |
Enrollment: | 16 |
Study Start Date: | October 1996 |
Study Completion Date: | June 2000 |
Primary Completion Date: | October 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HRT: Experimental
Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for days 13-22 and 1 mg 17β-estradiol/day for days 23-28 (Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark)
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Drug: Hormone replacement therapy
Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for days 13-22 and 1 mg 17β-estradiol/day for days 23-28 (Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark)
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Turner syndrome is due to the absence of a part of or the entire X chromosome in females. Stature is short, and morbidity is increased due to risk of osteoporosis and fractures, type 2 diabetes, ischemic heart disease, hypertension, and stroke, but also the risk of cirrhosis is increased. Clinical studies have shown a frequent occurrence of elevated liver enzymes, primarily alanine aminotransferase, g-glutamyl-transferase, and alkaline phosphatase, while bilirubin is normal.
We and others have shown a normalizing effect of hormone replacement therapy (HRT), containing 17bestradiol and a gestagen, on liver enzymes, which may point towards a protective effect on hepatocyte integrity. Marked architectural changes, including nodular regenerative hyperplasia, multiple focal nodular hyperplasia and cirrhosis are observed in some patients and are associated with a risk of liver-related complications. These changes are frequently associated with vascular disorders such as obliterative portal venopathy, probably related to congenitally abnormal vessels. Steatosis, steatofibrosis, and steatohepatitis are seen and may be caused by metabolic disorders. In addition, bile duct alterations resembling small duct sclerosing cholangitis are observed in several patients. Presently, it is not known whether these perturbations in liver morphology and in liver-derived enzymes are related to functional defects in females with TS and whether this may change by HRT. To further explore quantitative liver function in TS, we examined adult women with TS on and off HRT and compared them with a control group of age matched normal women. We used the galactose elimination capacity to assess hepatocyte cytosol activity, the plasma clearance of indocyanine green to assess hepatic blood flow and excretory liver cell function independently of hepatic blood flow, the antipyrine plasma clearance to estimate hepatic microsomal system activity, and the functional hepatic nitrogen clearance to assess mitochondrial- cytosolic metabolic capacity for conversion of amino-nitrogen.We assumed that one or more these metabolic liver functions would be diminished in untreated TS and normalized by HRT. Our principal objective was to understand mechanistically how HRT improves liver function in TS.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Jutland | |
Medical department M and Investigational Laboratories | |
Aarhus C, Jutland, Denmark, 8000 |
Principal Investigator: | J S Christíansen, Professor | Medical departmnet M, Aarhus University Hospital, NBG, Denamrk, |
Responsible Party: | Medical department M, Aarhus University Hospital, Denmark ( MD, PhD, DMSc Claus H. Gravholt ) |
Study ID Numbers: | 19963561 |
Study First Received: | January 20, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00825617 History of Changes |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee |
TS HRT Liver function tests |
Gonadal Disorders Hormone Antagonists Genital Dwarfism Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Chromosome Disorders Endocrine System Diseases Estradiol 17 beta-cypionate Ovarian Dwarfism Hormones Sex Differentiation Disorders Estradiol |
Monosomy X Turner Syndrome Urogenital Abnormalities Genetic Diseases, Inborn Norethindrone Estradiol 3-benzoate Endocrinopathy Polyestradiol phosphate Congenital Abnormalities Norethindrone acetate Gonadal Dysgenesis |
Disease Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Chromosome Disorders Endocrine System Diseases Hormones Sex Differentiation Disorders Pharmacologic Actions |
Turner Syndrome Pathologic Processes Urogenital Abnormalities Genetic Diseases, Inborn Syndrome Sex Chromosome Disorders Congenital Abnormalities Gonadal Dysgenesis |