CClinicalTrials.gg
Status unknownNCT01572259Updated Nov 17, 2015

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

A Phase 3 interventional study of Growth Hormone and interruption of the traitment with growth hormone in Atherosclerotic Cardiovascular Disease, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-17.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3 and Interventional

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Atherosclerotic Cardiovascular Disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    interruption of the growth hormone treatment.

    Other: interruption of the traitment with growth hormone

  • Experimental
    Patients traited by grouth hormone

    Drug: Growth Hormone

Interventions

  • DrugGrowth Hormone
  • Otherinterruption of the traitment with growth hormone
06

What researchers measure

Primary outcomes

  1. To measure of Growth hormone

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

    Time frame: 3 YEARS

Secondary outcomes

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

    Time frame: 3 YEARS

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34462238 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01572259
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Apr 6, 2012
Start date
Sep 2011
Primary completion
Mar 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Nov 17, 2015

Study contacts

RENE VALERO
Contact
rene.valero@ap-hm.fr
BERNARD BELAIGUES
study director · Assistance Publique hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion