Effect of Varying Testosterone Levels on Insulin Sensitiv... | NCT00470990

Studies
Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men

NCT00470990

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Apr 20, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hypogonadism

Interventions

GnRH antagonist (Acyline)

Countries

United States

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

Apr 2011

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 2002

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 2007Estimated

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

Apr 18, 2011

Last Update Posted Date

Apr 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

Collaborators

Name	Class
American Diabetes Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.

Detailed Description

The overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good general health and 2 groups of men will be studied in this protocol:

Thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone
Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GnRH antagonist (Acyline)	Drug	3 Subcutaneous injections (300 mcg/kg) over 36 days		IND # 62,621

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin sensitivity		2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Secondary Outcomes

Measure	Description	Time Frame
body composition		2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men:

Good general health,

Normotensive,
Normal testosterone levels,
No medications known to influence glucose homeostasis or testosterone levels

IHH men:

Good general health;
Normal thyroid, adrenal, and GH axes;
Normal prolactin levels;
No abnormalities on imaging of the hypothalamic-pituitary region;
No medications known to influence glucose homeostasis;
Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frances J Hayes, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02143	United States

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism
D017436	Kallmann Syndrome

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D058490	Disorder of Sex Development, 46,XY
D012734	Disorders of Sex Development

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C109238	acyline

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided