NCT00486161

Brief Summary

Ghrelin is a GH-secretagogue gastrointestinal hormone that regulates feeding behavior by interacting directly with hypothalamic centers in concert with other negative and permissive neuromodulators. Ghrelin is involved in controlling energy balance in the short-term and long-term, and its levels are inversely related to the degree of obesity, insulin-resistance and energy accumulation. Consequently, obesity bears decreased ghrelin levels which increase upon weight loss, energy depletion and long-term exercise programs. Nevertheless, the role of acute exercise on the secretion of the bioactive component of ghrelin is yet unknown in conditions of normal and excessive body weight. Our study examines acylated and total ghrelin secretion following a cycloergometric exercise test in obese and age- and sex-matched lean subjects to document if ghrelin components change as a function of fat accumulation, insulin homeostasis, growth hormone secretion, non-esterified fatty acid availability and exercise performance. Our study aims at testing the hypothesis that ghrelin components may be regulated by acute exercise, with concentrations at the exercise peak being related to acute metabolic homeostasis. Targetting this purpose may help to clarify ghrelin involvement in acute conditions unrelated to gastrointestinal activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2004

Typical duration for all trials

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

Study Start

First participant enrolled

March 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 12, 2007

Conditions

Keywords

ObesityGhrelinNon-esterified fatty acidsGrowth hormoneInsulinCycloergometer exercise

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy status
  • lean (BMI \< 25 kg/m2) and obese subjects (BMI\>30 kg/m2)

You may not qualify if:

  • cardiovascular disease
  • gastrointestinal disease
  • diabetes mellitus
  • alcohol consumption (wine or equivalents) \> 125 ml Day
  • physical inability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano, Ospedale San Giuseppe

Piancavallo Di Oggebbio, Verbania, 28921, Italy

Location

Related Publications (15)

  • Kojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K. Ghrelin is a growth-hormone-releasing acylated peptide from stomach. Nature. 1999 Dec 9;402(6762):656-60. doi: 10.1038/45230.

    PMID: 10604470BACKGROUND
  • Shintani M, Ogawa Y, Ebihara K, Aizawa-Abe M, Miyanaga F, Takaya K, Hayashi T, Inoue G, Hosoda K, Kojima M, Kangawa K, Nakao K. Ghrelin, an endogenous growth hormone secretagogue, is a novel orexigenic peptide that antagonizes leptin action through the activation of hypothalamic neuropeptide Y/Y1 receptor pathway. Diabetes. 2001 Feb;50(2):227-32. doi: 10.2337/diabetes.50.2.227.

    PMID: 11272130BACKGROUND
  • van der Lely AJ, Tschop M, Heiman ML, Ghigo E. Biological, physiological, pathophysiological, and pharmacological aspects of ghrelin. Endocr Rev. 2004 Jun;25(3):426-57. doi: 10.1210/er.2002-0029.

    PMID: 15180951BACKGROUND
  • Ariyasu H, Takaya K, Hosoda H, Iwakura H, Ebihara K, Mori K, Ogawa Y, Hosoda K, Akamizu T, Kojima M, Kangawa K, Nakao K. Delayed short-term secretory regulation of ghrelin in obese animals: evidenced by a specific RIA for the active form of ghrelin. Endocrinology. 2002 Sep;143(9):3341-50. doi: 10.1210/en.2002-220225.

    PMID: 12193546BACKGROUND
  • Baldanzi G, Filigheddu N, Cutrupi S, Catapano F, Bonissoni S, Fubini A, Malan D, Baj G, Granata R, Broglio F, Papotti M, Surico N, Bussolino F, Isgaard J, Deghenghi R, Sinigaglia F, Prat M, Muccioli G, Ghigo E, Graziani A. Ghrelin and des-acyl ghrelin inhibit cell death in cardiomyocytes and endothelial cells through ERK1/2 and PI 3-kinase/AKT. J Cell Biol. 2002 Dec 23;159(6):1029-37. doi: 10.1083/jcb.200207165. Epub 2002 Dec 16.

    PMID: 12486113BACKGROUND
  • Ghigo E, Broglio F, Arvat E, Maccario M, Papotti M, Muccioli G. Ghrelin: more than a natural GH secretagogue and/or an orexigenic factor. Clin Endocrinol (Oxf). 2005 Jan;62(1):1-17. doi: 10.1111/j.1365-2265.2004.02160.x.

    PMID: 15638864BACKGROUND
  • St-Pierre DH, Karelis AD, Coderre L, Malita F, Fontaine J, Mignault D, Brochu M, Bastard JP, Cianflone K, Doucet E, Imbeault P, Rabasa-Lhoret R. Association of acylated and nonacylated ghrelin with insulin sensitivity in overweight and obese postmenopausal women. J Clin Endocrinol Metab. 2007 Jan;92(1):264-9. doi: 10.1210/jc.2006-1603. Epub 2006 Oct 24.

    PMID: 17062757BACKGROUND
  • Korner J, Bessler M, Cirilo LJ, Conwell IM, Daud A, Restuccia NL, Wardlaw SL. Effects of Roux-en-Y gastric bypass surgery on fasting and postprandial concentrations of plasma ghrelin, peptide YY, and insulin. J Clin Endocrinol Metab. 2005 Jan;90(1):359-65. doi: 10.1210/jc.2004-1076. Epub 2004 Oct 13.

    PMID: 15483088BACKGROUND
  • Marzullo P, Verti B, Savia G, Walker GE, Guzzaloni G, Tagliaferri M, Di Blasio A, Liuzzi A. The relationship between active ghrelin levels and human obesity involves alterations in resting energy expenditure. J Clin Endocrinol Metab. 2004 Feb;89(2):936-9. doi: 10.1210/jc.2003-031328.

    PMID: 14764817BACKGROUND
  • Dall R, Kanaley J, Hansen TK, Moller N, Christiansen JS, Hosoda H, Kangawa K, Jorgensen JO. Plasma ghrelin levels during exercise in healthy subjects and in growth hormone-deficient patients. Eur J Endocrinol. 2002 Jul;147(1):65-70. doi: 10.1530/eje.0.1470065.

    PMID: 12088921BACKGROUND
  • Schmidt A, Maier C, Schaller G, Nowotny P, Bayerle-Eder M, Buranyi B, Luger A, Wolzt M. Acute exercise has no effect on ghrelin plasma concentrations. Horm Metab Res. 2004 Mar;36(3):174-7. doi: 10.1055/s-2004-814342.

    PMID: 15057671BACKGROUND
  • Kraemer RR, Durand RJ, Acevedo EO, Johnson LG, Kraemer GR, Hebert EP, Castracane VD. Rigorous running increases growth hormone and insulin-like growth factor-I without altering ghrelin. Exp Biol Med (Maywood). 2004 Mar;229(3):240-6. doi: 10.1177/153537020422900304.

    PMID: 14988516BACKGROUND
  • Vestergaard ET, Dall R, Lange KH, Kjaer M, Christiansen JS, Jorgensen JO. The ghrelin response to exercise before and after growth hormone administration. J Clin Endocrinol Metab. 2007 Jan;92(1):297-303. doi: 10.1210/jc.2006-1435. Epub 2006 Oct 10.

    PMID: 17032714BACKGROUND
  • Broom DR, Stensel DJ, Bishop NC, Burns SF, Miyashita M. Exercise-induced suppression of acylated ghrelin in humans. J Appl Physiol (1985). 2007 Jun;102(6):2165-71. doi: 10.1152/japplphysiol.00759.2006. Epub 2007 Mar 8.

    PMID: 17347386BACKGROUND
  • Marzullo P, Salvadori A, Brunani A, Verti B, Walker GE, Fanari P, Tovaglieri I, De Medici C, Savia G, Liuzzi A. Acylated ghrelin decreases during acute exercise in the lean and obese state. Clin Endocrinol (Oxf). 2008 Dec;69(6):970-1. doi: 10.1111/j.1365-2265.2008.03275.x. Epub 2008 Apr 14. No abstract available.

Related Links

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Paolo Marzullo, MD, PhD

    Division of General Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations