Substrate Metabolism and Insulin Sensitivity in Acromegal... | NCT00647179

Studies
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

NCT00647179

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 26, 2017Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Acromegaly
Excessive Growth Hormone Secretion
Insulin Resistance

Interventions

Transsphenoidal adenomectomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M-20070130

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Dec 7, 2016Actual

Completion Date

Dec 7, 2016Actual

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 28, 2008

First Posted Date

Mar 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2017

Last Update Posted Date

Dec 26, 2017Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients recently diagnosed with acromegaly	Procedure: Transsphenoidal adenomectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transsphenoidal adenomectomy	Procedure	Surgery	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		Before and after treatment

Secondary Outcomes

Measure	Description	Time Frame
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance		Before and after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written consent
Age between 18 and 70
Recently diagnosed with acromegaly

Exclusion Criteria:

NYHA 3
Uncontrolled hypertension
Known cerebrovascular disease
Proliferative retinopatia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patiens recently diagnoses with acromegaly, recruited from the clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Otto L. Jørgensen, Professor MD	Aarhus University Hospital, Department of Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Aarhus University Hospital		Aarhus C	Aarhus	DK-8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41701620	Derived	Baek A, Christiansen Arlien-Soborg M, Pedersen AKN, Dal J, Madsen MA, Hogild ML, Berryman D, Kopchick JJ, Pedersen SB, Bjerre M, Lebeck J, Jessen N, Jorgensen JOL. Growth hormone causes reversible fibrosis in muscle and fat: a study in patients with acromegaly. Eur J Endocrinol. 2026 Mar 4;194(3):299-306. doi: 10.1093/ejendo/lvag032.
31544947

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism

ID	Term
D000172	Acromegaly
D007333	Insulin Resistance