NCT00743327

Brief Summary

The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evaluate other cardiovascular risk factors in these men.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

3.8 years

First QC Date

August 26, 2008

Last Update Submit

August 3, 2012

Conditions

HypogonadismMetabolic SyndromeDiabetesInflammation

Keywords

hormone therapy

Outcome Measures

Primary Outcomes (1)

  • Evaluation for the development of incident diabetes

    every 3 months

Secondary Outcomes (1)

  • Evaluation for other cardiovascular risk factors, markers of inflammation and immunological changes

    every 3 months

Study Arms (3)

1

Participants receiving ADT and pioglitazone

Drug: Pioglitazone

2

Participants receiving ADT only

3

Participants not receiving ADT and in remission from prostate cancer

Interventions

PioglitazoneDRUG

45mg capsule, once daily for 1 year

Also known as: Actos
1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample of men ages 18 and older with prostate cancer

You may qualify if:

  • Men 18 years of age or older with prostate cancer
  • Planning to undergo long-term (at least 12 months) ADT
  • No known history of diabetes
  • No history of ADT

You may not qualify if:

  • History of ADT or any prior diagnosis of hypogonadism
  • Fasting glucose or oral glucose tolerance test results in the diabetic range
  • Heart failure (NY classification III or IV)
  • Testosterone level less than 250 ng/dl on screening
  • History of heart attack or open-heart surgery within the past 6 months
  • Use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable)
  • Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months
  • Liver function tests more than 3 times upper normal limits
  • Undergoing intermittent ADT
  • Uncontrolled thyroid disease (hyper- or hypo-thyroidism)
  • Anemia, defined as hematocrit less than 38%
  • Not physically capable of completing the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIA Clinical Research Unit located at Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Related Publications (5)

  • Dockery F, Bulpitt CJ, Agarwal S, Donaldson M, Rajkumar C. Testosterone suppression in men with prostate cancer leads to an increase in arterial stiffness and hyperinsulinaemia. Clin Sci (Lond). 2003 Feb;104(2):195-201. doi: 10.1042/CS20020209.

    PMID: 12546642BACKGROUND

  • Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.

    PMID: 16434464BACKGROUND

  • Basaria S, Muller DC, Carducci MA, Egan J, Dobs AS. Hyperglycemia and insulin resistance in men with prostate carcinoma who receive androgen-deprivation therapy. Cancer. 2006 Feb 1;106(3):581-8. doi: 10.1002/cncr.21642.

    PMID: 16388523BACKGROUND

  • Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497.

    PMID: 16983113BACKGROUND

  • Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741.

    PMID: 16921050BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Muscle biopsy specimens

MeSH Terms

Conditions

HypogonadismMetabolic SyndromeDiabetes MellitusInflammation

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Josephine M. Egan, MD

    National Institute on Aging, Intramural Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

US(1)