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

NCT ID: NCT01572259

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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interruption of the growth hormone treatment.

Group Type EXPERIMENTAL

interruption of the traitment with growth hormone

Intervention Type OTHER

Patients traited by grouth hormone

Group Type EXPERIMENTAL

Growth Hormone

Intervention Type DRUG

Interventions

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Growth Hormone

Intervention Type DRUG

interruption of the traitment with growth hormone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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RENE VALERO

Role: CONTACT

[email protected]

Facility Contacts

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rene Valero

Role: primary

[email protected]
0491387572

References

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Maraninchi M, Calabrese A, Nogueira JP, Castinetti F, Mancini J, Mourre F, Pietri L, Benamo E, Albarel F, Morange I, Dupont-Roussel J, Nicolay A, Brue T, Beliard S, Valero R. Role of growth hormone in hepatic and intestinal triglyceride-rich lipoprotein metabolism. J Clin Lipidol. 2021 Sep-Oct;15(5):712-723. doi: 10.1016/j.jacl.2021.08.003. Epub 2021 Aug 16.

Reference Type DERIVED
PMID: 34462238 (View on PubMed)

Other Identifiers

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2011-07

Identifier Type: OTHER

Identifier Source: secondary_id

2011-001688-34

Identifier Type: -

Identifier Source: org_study_id