PART FOUR
INFORMED CONSENT
The Effect of Testosterone Replacement
on Glucose Metabolism in Type II Diabetic Men

RETURN THESE MATERIALS TO:
Principle Investigator:

Edward M. Lichten, M.D.P.C.
180 East Brown Street
Birmingham, MI 48009

248.593.9999  fax:248.645-0066        Email: drlichten@yahoo.com

Project Number:609-97 Providence Hospital, Southfield, Michigan


BACKGROUND INFORMATION AND PURPOSE OF STUDY
Before I agree to participate in this study, it is important that I understand the purpose of the study and the procedures I will be asked to undergo. This consent also describes the benefits, risks, discomforts and precautions of this study.

STUDY PROCEDURES
The purpose of this research is to study whether administration of testosterone will improve the blood sugar abnormalities present in men with certain types of diabetes and low blood levels of testosterone. Testosterone is a hormone normally found in the blood. It is approved by the US Food and Drug Administration for treatment of men with low testosterone levels. Standard testosterone therapy may involve the use of a transdermal patch(patch attached to skin), intramuscular injection or oral treatment. Some studies have shown that the addition of testosterone can have positive effects on diabetes and lower the need for extra insulin or oral diabetes drugs.

If I agree to participate in this study, I must first undergo an evaluation of my prostate and bladder, and have a blood test to determine my prostate specific antigen (PSA) levels. If these are not normal, I will not be eligible for participation in the study. My doctor must supply the required laboratory tests as well as a detailed medical history and physical examination.

Testosterone can be replaced with pellets or liquid testosterone which will be used in this study. If I agree to participate, I will be randomly assigned (like flipping a coin) to a group that will receive testosterone injections or to a group that will receive placebo. Testosterone or placebo treatment will be given by injection of 2 cc of solution every week for 10 weeks. At 12 weeks, a blood sample will be drawn and processed. After a delay of less than one month, injections will be restarted with the alternative therapy. This way each individual will receive active drug for three months.

Participants in the study will also involve recording my daily glucose levels, insulin or oral diabetes drug use and sense of well-being. I will be given the option of recording my weekly frequency of intercourse as well.

RISKS
There are risks to using testosterone. Both injectable and skin applications of testosterone will suppress the body's production of testosterone. The testes ("balls" within the scrotal sac) will get smaller. This is usually temporary and is usually reversible when off the medication. Testosterone may increase or decrease one's sex drive. Testosterone treatment will supppress sperm production possibly making the individual temporarily sterile. However, no guarantee is made or implied that this acts as a contraceptive. I have advised my partner (if any) of these risks.

Testosterone may increase one's muscle development or strength. Testosterone may increase or decrease an individual's aggressive nature. Testosterone may increase the risk of blood clots in blood vessels. I also understand that there is a slight risk that the medication may temporarily or permanently lower my sperm count and contribute to infertility.

Testosterone may increase the growth of a testosterone sensitive cancer of the testes or prostate gland. Testosterone may increase your blood count necessitating that you donate blood at the Red Cross.

Testosterone may cause gallbladder disease or jaundice. Testosterone may be associated with obstructive sleep apnea. There are isolated cases of cancer of the kidneys, cancer of the seminal vesicles (testes), severe acne, enlargement of skin pores, liver damage, liver tumors and cancer and hyperprolactinemia (high breast milk inducing hormone). Testosterone may increase cholesterol level.

DISCOMFORTS:

The discomforts may include pain, bruising, infection and/or an allergic reaction in the injection site.There is a small risk of continued infection or bleeding at these sites. I agree to particpate knowing that there are a number of potential risks, including cancer, and risks yet unknown.

BENEFITS

Potential benefits are an improvement in my diabetes and an improved sense of well being. It is not guaranteed that I will benefit if I take part in this study.

COMPENSATION AND INJURY

I understand that there is no compensation for participating in this study. I also understand that ther is no compensation offered by Providence Hospital or any other federal, state, or private organization, for any physical or psychological injury which I may incur as a result of this study. While medial care is available should an injury occur, the cost of suchmeical care will be my responsibility. Additional costs are not anticipated.

QUESTIONS AND ALTENRATIVE PROCEDURES

If I have any questions about the study, at any time Dr. Lichten will answer them. [Email to: usdoctor@usdoctor.com]. He can be reached at (248)358-3433. If I have any questions, comments or concerns about the study or my rights as a research subject, I may call Denise Cunningham, R.N, at (248)424-3226.

I will also receive information on new findings which may develop during the course of the research and which might affect my willingness to voluntarily continue to paritcipate.

CONFIDENTIALITY

All information obtained from my participation in this study will be held strictly confidential within the limits of the law. In addition to the health care professionals caring for me, the Food and Drug Administration (FDA) may review my medical record. My identity will remain confidential if the results of the study are published.

VOLUNTARY PARTICIPATION

I understand that if I choose not to particpiate in this study, I will not be penalized in any way or lose any benefit. My participation in this study is voluntary. Should I choose to discontinue my participation in this study, It will not affect my relationship with my physician, or with Providence Hospital, nor will it affect my care in any way. I am free to withdraw my consent and discontinue my participation at any time during the study.

I understand that if I choose to withdraw from this study, I will inform my doctor in order to enable him to perform procedures for an orderly termination of my participation.

STATEMENT OF CONSENT

I have read this consent form and understand it. I voluntarily consent to participate in this research study.

I have been given a copy of this informed consent document to keep.

I also understand that by consenting to participate in this study, I am not waiving any other legal rights I may have arising from my participation in this study or as a patient at Providence Hospital.

_________________________(signature of patient) __________(date)

_________________________(signature of physician) __________(date)

_________________________(signature of witness) __________(date)


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