Research Protocolt
Adult Onset Diabetes in Men
Treatment with Testosterone

Edward M. Lichten, M.D.,PC
180 east Brown Street, Birmingham MI 48009: 248.593.9999

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

PART TWO: Required Initial Evaluation
Last Name_____________....Authorization Number:__________....Physician______________

History: MEN ONLY
  1. Last name, first name, birth date
  2. Phone number and identification number (chart or Social security)
  3. Age of Onset of Diabetes: History of effects of disease
  4. Complications of diabetes: including obesity, hypertension, heart disease
  5. All Medications used: past and present, indications
  6. Other medical and surgical conditions
  7. Smoking and alcohol history:
Physical Examination
  1. Height, weight, waist, hip and wrist measurements in inches
  2. Blood pressure
  3. Prostate examination
Laboratory Tests
  1. CBC
  2. SMA-12
  3. Lipids: Total cholesterol, LDL-C, HDL-C, triglycerides, ratio
  4. Hemoglobin A1C
  5. Fasting insulin: off oral agents for 2 days
  6. C-reactive Protein
  7. Homocysteine
  8. C-peptides (if available)
  9. Total Testosterone
  10. Free testosterone
  11. Sex Hormone Binding Globulin (SHBG)
  12. Estradiol (total)
  13. FSH and LH
  14. Thyroid: TSH, T3 free, T4 free
  15. DHEA-sulfate
  16. Prostate Specific Antigen
All non-insulin dependent diabetic men need to have a fasting, two-hour glucose test with insulin measurements at 0, 1, and 2 hours. The purpose of this test to to determine the 'insulin resistance' before and after testosterone treatment. As their blood glucose drops, they will be weaned off oral hypogylcemic agents. Insulin dependent diabetic men are followed for the decrease in amount of insulin needed to control their blood glucose. The end-point of the study is the change in hemoglobin A1C after three months of treatment.