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

Phase 3

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Other: interruption of the traitment with growth hormone; Drug: Growth Hormone

• Registration Number: NCT01572259
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interruption of the growth hormone treatment.	interruption of the traitment with growth hormone	-
Patients traited by grouth hormone	Growth Hormone	-

Primary Outcome Measures

Name	Time	Method
To measure of Growth hormone	3 YEARS	that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL	3 YEARS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France