NCT00652379

Brief Summary

The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy. Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

March 26, 2008

Last Update Submit

January 25, 2012

Conditions

AcromegalyInsulin ResistanceImpaired Glucose Tolerance

Keywords

AcromegalyInsulin sensitivityGlucose toleranceBody compositionGrowth Hormone

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    0 and after 24 weeks

Secondary Outcomes (4)

  • Glucose tolerance

    0 and after 24 weeks

  • Symptoms, QoL questionaire

    0, 12 and 24 weeks

  • Intrahepatic and intramyocellular fat

    0 and 24 weeks

  • Substrate metabolism

    0 and 24 weeks

Study Arms (2)

1

EXPERIMENTAL

Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose

Drug: PegvisomantDrug: Somatostatin analog (lanreotide or octreotide)

2

ACTIVE COMPARATOR

Somatostatin analog, unaltered dosage

Drug: Somatostatin analog (lanreotide or octreotide)

Interventions

PegvisomantDRUG

Pegvisomant s.c 15-30 mg 2 times a week

Also known as: Somavert
1
Somatostatin analog (lanreotide or octreotide)DRUG

Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

12

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Diagnosed with acromegaly
  • Safe anticonceptive for fertile women
  • Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH \< 0.5 µg/l.)

You may not qualify if:

  • Pregnancy
  • Liver disease
  • Diabetes mellitus type I
  • Magnetic or electronic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Aarhus University Hospital

Aarhus C, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

AcromegalyInsulin ResistanceGlucose Intolerance

Interventions

pegvisomantSomatostatinlanreotideOctreotide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jens Otto L. Jørgensen, MD Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

April 3, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

May 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

DK(1)