Peripheral Metabolic Effects of Somatostatin | NCT01062529

Studies
Peripheral Metabolic Effects of Somatostatin

NCT01062529

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Acromegaly
Growth Hormone Deficiency
Diabetes

Interventions

Somatostatin

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

Jan 2013

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

Oct 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jan 28, 2010

First Submission Date that Met QC Criteria

Feb 3, 2010

First Posted Date

Feb 4, 2010Estimated

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

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Name	Class
The Ministry of Science, Technology and Innovation, Denmark	OTHER_GOV

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 aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
somatostatin	Experimental		Drug: Somatostatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatostatin	Drug	4 h of 150 microgram infusion	somatostatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma levels of glucose		3 months

Secondary Outcomes

Measure	Description	Time Frame
GH signalling		one year
Serum levels of free fatty acids (FFA)		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI < 27 kg/m2
Written informed consent
Healthy

Exclusion Criteria:

Any disease
Any use of medications
Present or previous malignancy
Alcohol dependency
Allergy to trial medication

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 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 Otto L Jørgensen, Professor		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical department M		Aarhus	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly
D004393	Dwarfism, Pituitary
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013004	Somatostatin

Ancestor Terms

ID	Term
D010905	Pituitary Hormone Release Inhibiting Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided