NCT00438321

Brief Summary

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2010

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

February 20, 2007

Last Update Submit

April 14, 2017

Conditions

Metabolic Syndrome

Keywords

Overweightobesitytestosteronediabetesmetabolic syndromeaging

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Assessed by euglycemic-hyperinsulinemic clamp

    3 months

Secondary Outcomes (4)

  • Resting energy expenditure

    3 months

  • Lipid profile

    3 months

  • Body composition

    3 months

  • Intramyocellular fat

    3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo injection, gel and pill

Other: Placebo

Testosterone only

ACTIVE COMPARATOR

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily

Drug: ZoladexDrug: Testosterone gelDrug: Anastrozole Pill

Testosterone and Estrogen

ACTIVE COMPARATOR

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily

Drug: ZoladexDrug: Testosterone gel

Interventions

ZoladexDRUG
Testosterone and EstrogenTestosterone only
Testosterone gelDRUG
Also known as: AndroGel
Testosterone and EstrogenTestosterone only
Anastrozole PillDRUG
Also known as: Arimidex
Testosterone only
PlaceboOTHER
Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)

You may not qualify if:

  • No new diagnosis of type 2 diabetes or on oral hypoglycemic agents
  • No history of testicular disorders
  • No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome)
  • No history of prostate cancer
  • No previous diagnosis of osteoporosis
  • No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)
  • No symptoms of urinary outflow obstruction or medications for prostate disease
  • No illicit drug use or heavy alcohol use (\>4 drinks/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Pitteloud N, Hardin M, Dwyer AA, Valassi E, Yialamas M, Elahi D, Hayes FJ. Increasing insulin resistance is associated with a decrease in Leydig cell testosterone secretion in men. J Clin Endocrinol Metab. 2005 May;90(5):2636-41. doi: 10.1210/jc.2004-2190. Epub 2005 Feb 15.

    PMID: 15713702BACKGROUND

  • Pitteloud N, Mootha VK, Dwyer AA, Hardin M, Lee H, Eriksson KF, Tripathy D, Yialamas M, Groop L, Elahi D, Hayes FJ. Relationship between testosterone levels, insulin sensitivity, and mitochondrial function in men. Diabetes Care. 2005 Jul;28(7):1636-42. doi: 10.2337/diacare.28.7.1636.

    PMID: 15983313BACKGROUND

Related Links

MeSH Terms

Conditions

Metabolic SyndromeOverweightObesityDiabetes Mellitus

Interventions

GoserelinTestosteroneAnastrozole

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Frances J Hayes, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

September 1, 2006

Primary Completion

February 26, 2010

Study Completion

February 26, 2010

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)