NCT00647179

Brief Summary

The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 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

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2016

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

8.9 years

First QC Date

March 26, 2008

Last Update Submit

December 22, 2017

Conditions

AcromegalyExcessive Growth Hormone SecretionInsulin Resistance

Keywords

AcromegalyGrowth HormoneInsulin resistanceGlucose toleranceBody CompositionSubstrate metabolism

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Before and after treatment

Secondary Outcomes (1)

  • QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance

    Before and after treatment

Study Arms (1)

1

Patients recently diagnosed with acromegaly

Procedure: Transsphenoidal adenomectomy

Interventions

Transsphenoidal adenomectomyPROCEDURE

Surgery

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patiens recently diagnoses with acromegaly, recruited from the clinic

You may qualify if:

  • Written consent
  • Age between 18 and 70
  • Recently diagnosed with acromegaly

You may not qualify if:

  • NYHA 3
  • Uncontrolled hypertension
  • Known cerebrovascular disease
  • Proliferative retinopatia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Aarhus University Hospital

Aarhus C, Aarhus, DK-8000, Denmark

Location

Related Publications (1)

  • Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033.

    PMID: 31544947DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, muscle samples, fat samples

MeSH Terms

Conditions

AcromegalyInsulin Resistance

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jens Otto L. Jørgensen, Professor MD

    Aarhus University Hospital, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

February 1, 2008

Primary Completion

December 7, 2016

Study Completion

December 7, 2016

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

DK(1)