Case Report: Breakthrough In Controlling the Most Severe Diabetes
Edward Lichten, M.D.,PC
OVERVIEW: Submitted as a Case Report to the JAMA 1/27/2007.
It appears that even the worst adult diabetic can reach levels of improved or near normal glycemic control with the use of testosterone. Our recent experience is described herein:
A.M. is a 50-year African-American male, weighting 250 pounds seen on July 17, 2006. He reports being on 15 units of insulin twice daily for his diabetes for at least 5 years. His fasting glucose was 488 mg/ml and his hemoglobin-A1c (Hgb-A1c) was greater than 18%. Although his testosterone level was 643 ng/dL, Estradiol 43 pg/ml and Sex Hormone Binding Globulin 38 nmol/L, his calculated Free Androgen Index1 was well below the normal range of 0.7 to 1.0. FAI=/(30x 38]. [30 is the conversion factor from nmol/L to ng/dL]. On testosterone injections, he gained significant glycemic control in 24 weeks as shown in Table 1. Accidental injection of 30 units of Humulin-R instead of Humulin 70/30 did not precipitate a hypoglycemic crisis. His Hgb-A1c is expected to drop even lower as true stabilization is reached in the next two months.
Testosterone deficiency exists in all diabetic men2 and therefore, there is a logic in beginning replacement therapy with testosterone3 since testosterone reduces insulin resistance4. As Ding surmised in his meta-analysis of diabetic databases:
1) “Cross-sectional studies indicated that testosterone level was significantly lower in men with type 2 diabetes”
2) “Prospective studies showed that men with higher testosterone levels (range, 449.6-605.2 ng/dL) had a 42% lower risk of type 2 diabetes”
We have more than 10 years experience in replacing testosterone in adult diabetic men as a result of an IRB supervised study #609-97 at Providence Hospital in Southfield, Michigan in 1997-1999.
The IRB protocol originally identified 50 adult, hypogonal diabetic men with Type I (15 men requiring insulin) and Type II (35 men on oral hypoglycemic agents). The protocol was to supplement testosterone with injections or implanted pellets. Injectable testosterone replacement of approximately 400 mg per month resulted in physiological midrange testosterone level values (550-900 ng/dl). The observed volunteers were able to reduce their diabetic medication requirements by 25-50% while improving their laboratory glycemic measurements of fasting glucose and glycogenated hemoglobin. Jens Moller5 in 1987 reported treating thousands of diabetics with injections of testosterone.
In the CASE REPORT, aggressive testosterone and insulin management allowed this man to reach tight glycemic control. And while insulin is prescribed to approximately 10% of diabetics, it is expected that a full 50% of diabetics, that being all men, may benefit from routine testosterone replacement. Testosterone is approved and appropriate for hypogonadal men without evidence of prostate or testicular cancer, so it can be prescribed for men with incidental diabetes. Furthermore, Morgantaler5 stated that testosterone would not increase the risk of prostate cancer when normal prostate specific antigen (PSA) and prostate monitoring is regularly performed.
With tight glycemic control reducing the morbidity and mortality of this disease6, using testosterone freely may change the entire management of diabetes in men.
EML had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
The IRB study was funded by Providence Hospital Research Foundation.