Androgen Deprivation Therapy Study (ADT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743327
Recruitment Status : Terminated (No Participants completed study)
First Posted : August 28, 2008
Last Update Posted : August 6, 2012
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

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.

Condition or disease Intervention/treatment
Hypogonadism Metabolic Syndrome Diabetes Inflammation Drug: Pioglitazone

Detailed Description:

Lowering of testosterone levels, by medications or surgery (Androgen Deprivation Therapy or ADT), is commonly used in the treatment of prostate cancer. The adverse effects of low testosterone include decreased sex drive, impotence, decreased lean body mass and muscle strength, increased fat mass, decreased quality of life and osteoporosis.

An increase in body fat and decrease in lean body mass may contribute to a decrease in the body's ability to use insulin effectively, leading to insulin resistance and diabetes. Low testosterone levels are also associated with elevated total cholesterol, LDL-cholesterol and triglycerides.

Two groups of non-diabetic men will be studied:

  1. Men with known history of prostate cancer who were treated with surgery and/or radiation therapy and are now in remission and not receiving androgen deprivation therapy (non-ADT group).
  2. Men with newly diagnosed or known history of prostate cancer who are being advised by their physicians to begin androgen deprivation therapy (ADT group).

The non-ADT group and half of the ADT group will be observed for the development of insulin resistance/diabetes. The other half of the ADT group will receive a diabetes medication called Pioglitazone (Actos) to evaluate any beneficial effects of this medication in the prevention of metabolic dysfunction.

The study will consist of a screening visit and 6 additional study visits throughout one year. Procedures during this study include blood draws, MRI, CT, DEXA scan, insulin clamp procedures, oral glucose tolerance tests, carotid IMT, pulse wave velocity, neuropsychological testing, physical exams and an optional muscle biopsy.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic and Cardiovascular Complications in Men With Prostate Cancer Undergoing Long-term Androgen Deprivation Therapy
Study Start Date : October 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Group/Cohort Intervention/treatment
Participants receiving ADT and pioglitazone
Drug: Pioglitazone
45mg capsule, once daily for 1 year
Other Name: Actos

Participants receiving ADT only
Participants not receiving ADT and in remission from prostate cancer

Primary Outcome Measures :
  1. Evaluation for the development of incident diabetes [ Time Frame: every 3 months ]

Secondary Outcome Measures :
  1. Evaluation for other cardiovascular risk factors, markers of inflammation and immunological changes [ Time Frame: every 3 months ]

Biospecimen Retention:   Samples Without DNA
Serum, Muscle biopsy specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample of men ages 18 and older with prostate cancer

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743327

United States, Maryland
NIA Clinical Research Unit located at Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Josephine M. Egan, MD National Institute on Aging, Intramural Research Program

Responsible Party: National Institute on Aging (NIA) Identifier: NCT00743327     History of Changes
Other Study ID Numbers: AG0107
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
hormone therapy

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists