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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01572259
First received: October 6, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Atherosclerotic Cardiovascular Disease
Drug: Growth Hormone
Other: interruption of the traitment with growth hormone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To measure of Growth hormone [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity


Secondary Outcome Measures:
  • to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interruption of the growth hormone treatment. Other: interruption of the traitment with growth hormone
Experimental: Patients traited by grouth hormone Drug: Growth Hormone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572259

Contacts
Contact: RENE VALERO rene.valero@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: rene Valero    0491387572    rene.valero@ap-hm.fr   
Principal Investigator: rene VALERO         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01572259     History of Changes
Other Study ID Numbers: 2011-001688-34, 2011-07
Study First Received: October 6, 2011
Last Updated: August 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cardiovascular Diseases
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014