Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

NCT01807364 | Completed

• 2 other identifiers: AOR 10032P091106
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

Conditions

Congenital Adrenal Hyperplasia

Keywords

Congenital adrenal hyperplasia (CAH); Cardiovascular risk; Microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

• Ultrasound evaluation of intima-media thickness

  Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function

  day 1

Secondary Outcomes (14)

• Blood pressure

  day 1

• Skin capillary density

  day 1

• Insulin during an oral glucose tolerance test

  day 1

• Circulating cardiovascular risk markers

  day 1

• Lipid profile

  day 1

Study Arms (2)

Congenital adrenal hyperplasia

Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood

controls

control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood and controls

You may qualify if:

• Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
• Absence of known cardiovascular disease
• Absence of combined oral contraceptives during the previous month
• Age \> 18 yrs
• Absence of known cardiovascular disease
• Absence of combined oral contraceptives during the previous month

You may not qualify if:

• Blood donation during the previous 3 months
• Cardiovascular disease
• Treatment by combined oral contraceptives
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Anne Bachelot, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: March 8, 2013
• Study Start: May 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)