NCT00459940

Brief Summary

In the present double blind, placebo-controlled, parallel study we evaluated the impact of 12 weeks thiazolidinedione (TZD) administration on basal and insulin-stimulated substrate metabolism in growth hormone-replaced adults with growth hormone deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
Last Updated

April 13, 2007

Status Verified

April 1, 2007

First QC Date

April 12, 2007

Last Update Submit

April 12, 2007

Conditions

Growth Hormone Deficiency

Keywords

Growth hormoneLipolysisInsulin resistancePioglitazoneGrowth hormone replaced growth hormone deficient adults

Outcome Measures

Primary Outcomes (3)

  • Circulating FFA level

  • FFA turnover

  • Lipid oxidation

Interventions

PioglitazoneDRUG

Eligibility Criteria

Age19 Years - 71 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Growth hormone replaced (minimum 6 months) growth hormone deficient men
  • Age over 18 years

You may not qualify if:

  • Ischemic coronary disease, defined by EF\<0.6, former myocardial infarction, angina pectoris or actual treatment of cardiac insufficiency
  • Actual or former malignancy, except intracranial neoplasia that caused the participants pituitary disease, provided that there was clinical evidence for permanent remission
  • Blood donation within 6 months
  • Excessive alcohol consumption
  • Known allergic reaction from contents of test drug
  • Radioactive radiation exposure in terms of treatment or study enrollment within one year
  • Liver insufficiency
  • Insulin treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department M, The Medical Research Laboratories, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (7)

  • Boden G, Cheung P, Mozzoli M, Fried SK. Effect of thiazolidinediones on glucose and fatty acid metabolism in patients with type 2 diabetes. Metabolism. 2003 Jun;52(6):753-9. doi: 10.1016/s0026-0495(03)00055-6.

    PMID: 12800103BACKGROUND

  • Racette SB, Davis AO, McGill JB, Klein S. Thiazolidinediones enhance insulin-mediated suppression of fatty acid flux in type 2 diabetes mellitus. Metabolism. 2002 Feb;51(2):169-74. doi: 10.1053/meta.2002.29981.

    PMID: 11833043BACKGROUND

  • Alford FP, Hew FL, Christopher MC, Rantzau C. Insulin sensitivity in growth hormone (GH)-deficient adults and effect of GH replacement therapy. J Endocrinol Invest. 1999;22(5 Suppl):28-32.

    PMID: 10442567BACKGROUND

  • Spiegelman BM. PPAR-gamma: adipogenic regulator and thiazolidinedione receptor. Diabetes. 1998 Apr;47(4):507-14. doi: 10.2337/diabetes.47.4.507.

    PMID: 9568680BACKGROUND

  • Nielsen S, Moller N, Christiansen JS, Jorgensen JO. Pharmacological antilipolysis restores insulin sensitivity during growth hormone exposure. Diabetes. 2001 Oct;50(10):2301-8. doi: 10.2337/diabetes.50.10.2301.

    PMID: 11574412BACKGROUND

  • Nielsen S, Moller N, Pedersen SB, Christiansen JS, Jorgensen JO. The effect of long-term pharmacological antilipolysis on substrate metabolism in growth hormone (GH)-substituted GH-deficient adults. J Clin Endocrinol Metab. 2002 Jul;87(7):3274-8. doi: 10.1210/jcem.87.7.8597.

    PMID: 12107236BACKGROUND

  • Norrelund H, Djurhuus C, Jorgensen JO, Nielsen S, Nair KS, Schmitz O, Christiansen JS, Moller N. Effects of GH on urea, glucose and lipid metabolism, and insulin sensitivity during fasting in GH-deficient patients. Am J Physiol Endocrinol Metab. 2003 Oct;285(4):E737-43. doi: 10.1152/ajpendo.00092.2003. Epub 2003 Jun 10.

    PMID: 12799313BACKGROUND

MeSH Terms

Conditions

Dwarfism, PituitaryInsulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jens OL Jorgensen, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2007

First Posted

April 13, 2007

Study Start

September 1, 2004

Study Completion

March 1, 2006

Last Updated

April 13, 2007

Record last verified: 2007-04

Locations

DK(1)