Insulin Sensitivity and Substrate Metabolism Before and A... | NCT00646815

Studies
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

NCT00646815

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 22, 2009Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Growth Hormone Deficiency

Interventions

growth hormone (genotropin)

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

Status Module

Record Verification Date

Oct 2009

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

Mar 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 19, 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

Oct 21, 2009

Last Update Posted Date

Oct 22, 2009Estimated

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 further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
a	Experimental	the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency	Drug: growth hormone (genotropin)
Control	No Intervention	Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
growth hormone (genotropin)	Drug	Dosage regulation will follow the local recommendations of GHD treatment	a

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin sensitivity		before and after 3 months treatment with growth hormone

Secondary Outcomes

Measure	Description	Time Frame
substrate metabolism		before and after 3 months of growth hormone treatment
intrahepatic lipid content		before and after 3 months of growth hormone treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Must be of legal age and competent
Age: >18 and <60 years old
Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study

Exclusion Criteria:

Alcohol consumption >21 units per week
Malignant disease
Pregnancy
Magnetic implants or material in the body
Claustrophobia
BMI >30
Heart disease (NYHA >2)
Uncontrolled hypertension
Manifest diabetes mellitus
Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Controls are matched on age, gender and BMI

Inclusion Criteria:

Written informed consent
Must be of legal age and competent

Exclusion Criteria:

Alcohol consumption >21 units per week
Malignant disease
Pregnancy
Magnetic implants or material in the body
Claustrophobia
Heart disease (NYHA >2)
Uncontrolled hypertension
Manifest diabetes mellitus
Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens OL Jorgensen, Professor MD	Medical Department M, Aarhus University Hospital, Aarhus, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.		Aarhus	Aarhus	8000	Denmark

Label	URL
Danish Data Protection Agency	View source

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary
D007333	Insulin Resistance
D005234	Fatty Liver

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided