Cardiac Steatosis in Cushing's Syndrome

NCT02202902 | Unknown

• 2 other identifiers: AOR120172013-A01023-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

Conditions

Endocrine System Disease; Cardiovascular Imaging

Keywords

Cushing's syndrome; cardiac steatosis; intramyocardial triglyceride content; 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging; Left Ventricularly hypertrophy

Outcome Measures

Primary Outcomes (1)

• Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio

  Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy

  Assessed twice in patients - before and 6 months after treatment - and once in volunteers

Secondary Outcomes (3)

• Left Ventricular intramyocardial fatt fraction (Dixon)

  Assessed twice in patients - before and 6 months after treatment - and once in volunteers

• Subcutaneous and visceral abdominal fatt

  Assessed twice in patients - before and 6 months after treatment - and once in volunteers

• Cardiac morphology and function

  Assessed twice in patients - before and 6 months after treatment - and once in volunteers

Study Arms (3)

Group 1 : 1H magnetic resonance spectroscopy and CMRI

EXPERIMENTAL

Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance

Other: 1H magnetic resonance spectroscopy and CMRI

Group 2 : 1H magnetic resonance spectroscopy and CMRI

EXPERIMENTAL

Group 2: Cushing's syndrome patients with normal glucose intolerance

Other: 1H magnetic resonance spectroscopy and CMRI

Group 3 : 1H magnetic resonance spectroscopy and CMRI

EXPERIMENTAL

age-, sex- and BMI-matched healthy volunteers

Other: 1H magnetic resonance spectroscopy and CMRI

Interventions

1H magnetic resonance spectroscopy and CMRI OTHER

Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment

Also known as: Before and after Treatment

Group 1 : 1H magnetic resonance spectroscopy and CMRI; Group 2 : 1H magnetic resonance spectroscopy and CMRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance
• group 3: healthy volunteers matched for age, sex and BMI with the patients of the group 2

You may not qualify if:

• contraindication of MRI
• hypersensitivity to gadolinium
• acute myocardial ischemia
• renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
• pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Related Publications (1)

• Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.

  PMID: 34333603 DERIVED

MeSH Terms

Conditions

Endocrine System Diseases; Cushing Syndrome

Interventions

Lead; Aftercare; Detection Algorithms

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Algorithms; Mathematical Concepts

Study Officials

• Philippe CHANSON, MD, PhD

  AP-HP, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CHANSON, MD, PhD

CONTACT

+33 (0)1 45 21 37 05; philippe.chanson@bct.aphp.fr

Peter KAMENICKY, MD

CONTACT

+33 (0)1 45 21 37 06; peter.kamenicky@bct.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

FR (1)