NCT01572259

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 17, 2015

Status Verified

August 1, 2015

Enrollment Period

4.5 years

First QC Date

October 6, 2011

Last Update Submit

November 16, 2015

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • To measure of Growth hormone

    that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity

    3 YEARS

Secondary Outcomes (1)

  • to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL

    3 YEARS

Study Arms (2)

interruption of the growth hormone treatment.

EXPERIMENTAL
Other: interruption of the traitment with growth hormone

Patients traited by grouth hormone

EXPERIMENTAL
Drug: Growth Hormone

Interventions

Growth HormoneDRUG
Patients traited by grouth hormone
interruption of the traitment with growth hormoneOTHER
interruption of the growth hormone treatment.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34462238DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

RENE VALERO

CONTACT

rene.valero@ap-hm.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

April 6, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

November 17, 2015

Record last verified: 2015-08

Locations

FR(1)