NCT01209416

Brief Summary

This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as signal proteins in fat and muscle biopsies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

September 24, 2010

Last Update Submit

October 27, 2017

Conditions

MetabolismInsulin ResistanceHypopituitarism

Keywords

ghrelinmetabolismtype 2 diabetesinsulin resistance

Outcome Measures

Primary Outcomes (3)

  • Effects of ghrelin during basal and hyperinsulinemic conditions

    Growth hormone deficient patient investigated with ghrelin infusion and pharmacological antilipolysis (Acipimox) in a randomized cross-over study with 4 study days. During each visit signal proteins in muscle and fat biopsies are investigated with PCR, wester blot and activity assays for ghrelin, growth hormone and insulin. Further is glucose metabolism investigated in basal conditions and during hyperinsulinemic euglycemic clamp.

    5 hours investigation day

  • Effects of ghrelin during basal and hyperinsulinemic conditions

    Effects of ghrelin on heart rate variability

    5 hours investigation day

  • Effects of ghrelin during basal and hyperinsulinemic conditions

    Effects of ghrelin on thirst, fluid intake, urine production and natriuresis

    5 hours investigation day

Study Arms (4)

Ghrelin / Acipimox

ACTIVE COMPARATOR

Ghrelin infusion and tablet acipimox

Drug: AcipimoxDrug: Ghrelin

Ghrelin / placebo

ACTIVE COMPARATOR

Ghrelin infusion and placebo tablets

Drug: GhrelinOther: Placebo

Placebo / Acipimox

ACTIVE COMPARATOR

saline infusion and tablet Acipimox

Drug: AcipimoxOther: Placebo

Placebo / placebo

PLACEBO COMPARATOR

saline infusion and placebo tablets

Other: Placebo

Interventions

AcipimoxDRUG

Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Also known as: Tablet Olbetam 250 mg
Ghrelin / AcipimoxPlacebo / Acipimox
GhrelinDRUG

Ghrelin infusion 4.2 ng/kg/min throughout the investigation day

Ghrelin / AcipimoxGhrelin / placebo
PlaceboOTHER

placebo tablets or saline infusion

Also known as: Placebo tablets, Saline infusion
Ghrelin / placeboPlacebo / AcipimoxPlacebo / placebo

Eligibility Criteria

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

You may qualify if:

  • males with hypopituitarism in regard to growth hormone and ACTH in stabile treatment regime
  • age 18-65
  • BMI 20-35

You may not qualify if:

  • abuse of alcohol
  • malign disease
  • medication other than that expected for hypopituitarism
  • known disease other than hypopituitarism
  • participation in isotope investigations the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • Jepsen SL, Vestergaard ET, Larraufie P, Gribble FM, Reimann F, Jorgensen JOL, Holst JJ, Kuhre RE. Ghrelin Does Not Directly Stimulate Secretion of Glucagon-like Peptide-1. J Clin Endocrinol Metab. 2020 Jan 1;105(1):266-75. doi: 10.1210/clinem/dgz046.

    PMID: 31608930DERIVED

  • Vestergaard ET, Cichosz SL, Moller N, Jorgensen JOL, Fleischer J. Short-term acipimox treatment is associated with decreased cardiac parasympathetic modulation. Br J Clin Pharmacol. 2017 Dec;83(12):2671-2677. doi: 10.1111/bcp.13384. Epub 2017 Aug 24.

    PMID: 28736944DERIVED

Related Links

MeSH Terms

Conditions

Insulin ResistanceHypopituitarismDiabetes Mellitus, Type 2

Interventions

acipimoxGhrelin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesDiabetes Mellitus

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jens Otto L Jørgensen, Professor

    University Hospital of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 27, 2010

Study Start

June 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

October 30, 2017

Record last verified: 2017-05

Locations

DK(1)