Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

Atherosclerotic Cardiovascular Disease Clinical Trial

Official title:

Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572259
• Other study ID #: 2011-001688-34
• Secondary ID: 2011-07
• Status: Recruiting
• Phase: Phase 3
• First received: October 6, 2011
• Last updated: November 16, 2015
• Start date: September 2011
• Est. completion date: March 2017

Study information

• Verified date: August 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: RENE VALERO
• Email: rene.valero[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Male or feminine

• age from 18 to 70 years

• deficit in growth hormone informed by a peak lower than 10 mUI / l in answer to a test of hypoglycemia (or another test of stimulation if the hypoglycemia insulinique is dissuaded) (cf. attached the RCP of various growth hormone used at the adult)

• centre (treatments optimized previously will be maintained during all the duration of the study) thyréotrope, corticotrope and gonadotrope substituted well for at least 6 months

• IMC(CEREBRAL-MOTOR HANDICAPPED) < 30 kg / m2

• fasting blood glucose < 1,26 g/L

• clearance of the creatinine > 60 ml / min

Exclusion Criteria:

Nobody particularly protected: incapable major and private person of freedom, person hospitalized for another pathology; · nobody mastering the reading of the French language

• carrier patients of a tumor in service

• pregnant woman

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Growth Hormone

Other:
• interruption of the traitment with growth hormone

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure of Growth hormone	that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity	3 YEARS	No
Secondary	to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL		3 YEARS	No