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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Unknown
Phase 3

Conditions

Atherosclerotic Cardiovascular Disease

Treatments

Other: interruption of the traitment with growth hormone
Drug: Growth Hormone

Study type

Interventional

Funder types

Other

Identifiers

NCT01572259
2011-001688-34
2011-07 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

interruption of the growth hormone treatment.
Experimental group
Treatment:
Other: interruption of the traitment with growth hormone
Patients traited by grouth hormone
Experimental group
Treatment:
Drug: Growth Hormone

Trial contacts and locations

1

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Central trial contact

RENE VALERO

Data sourced from clinicaltrials.gov

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