NCT00487734

Brief Summary

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

3.2 years

First QC Date

June 15, 2007

Last Update Submit

October 22, 2012

Conditions

Metabolic SyndromeHypogonadism

Keywords

Metabolic SyndromeHypogonadismInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity as measured by HOMA-IR

    18 weeks

Secondary Outcomes (3)

  • Changes in parameters of the Metabolic Syndrome

    18 weeks

  • Changes in body composition

    18 weeks

  • Changes in total and high MW adiponectin levels

    18 weeks

Study Arms (2)

1

EXPERIMENTAL

Subjects in this arm will receive testosterone gel

Radiation: Testosterone gel

2

PLACEBO COMPARATOR
Drug: Placebo for testosterone gel

Interventions

Testosterone gelRADIATION

testosterone gel, applied daily. Dosed to achieve testosterone level \<500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.

Also known as: Androgel
1
Placebo for testosterone gelDRUG

Placebo gel, 2.5g for each gel packet

2

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic syndrome (have 3 out of the following 4 criteria):
  • BP \> 130/85 or on antihypertensive therapy
  • Fasting glucose \> 100 mg/dl
  • Fasting TG \> 150 mg/dl or on a triglyceride lowering agent (fenofibrate, gemfibrozil, niacin in doses of \>= 500 mg/day, or fish oils in doses of \>=2000mg DHA+EPA)
  • Fasting HDL-C \< 40 mg/dl Note that the waist circumference will not be used as one of the criteria for the metabolic syndrome for this study because we are studying non-obese subjects.
  • Total Testosterone less than 300 ng/dl

You may not qualify if:

  • Women.
  • Men less than 20 years of age.
  • BMI \> or = to 30 kg/M2.
  • Use of testosterone preparations within 1 year of the screening visit
  • Use of hypoglycemic medications within the previous 3 months.
  • Fasting blood glucose \> 126 mg/dl.
  • The following men will be excluded because of the potential safety issues in the placebo treated group:
  • Creatinine greater than 1.4 mg/dl
  • Triglyceride levels greater than 500 mg/dl
  • HDL-C levels less than 20 mg/dl
  • Blood pressure greater than 160/90
  • The following men will be excluded because of the potential side effects of testosterone therapy:
  • Men greater than 65 years of age
  • International prostate symptom score \>19
  • PSA greater than 2.5
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeHypogonadismInsulin Resistance

Interventions

Testosterone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sonja K Fredrickson, MD

    Hunter Holmes McGuire VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 19, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

US(1)