Treatment of hypogonadism with testosterone in patients with type 2 diabetes mellitus.
OBJECTIVE
To investigate the effect of testosterone treatment on insulin resistance, glycemic control, and dyslipidemia in Asian Indian men with type 2 diabetes mellitus (T2DM) and hypogonadism.


METHODS
We conducted a double-blind, placebo-controlled, crossover study in 22 men, 25 to 50 years old, with T2DM and hypogonadism. Patients were treated with intramuscularly administered testosterone (200 mg every 15 days) or placebo for 3 months in random order, followed by a washout period of 1 month before the alternative treatment phase. The primary outcomes were changes in fasting insulin sensitivity (as measured by homeostasis model assessment [HOMA] in those patients not receiving insulin), fasting blood glucose, and hemoglobin A1c. The secondary outcomes were changes in fasting lipids, blood pressure, body mass index, waist circumference, waist-to-hip ratio, and androgen deficiency symptoms. Statistical analysis was performed on the delta values, with the treatment effect of placebo compared with the effect of testosterone.


RESULTS
Treatment with testosterone did not significantly influence insulin resistance measured by the HOMA index (mean treatment effect, 1.67 +/- 4.29; confidence interval, -6.91 to 10.25; P>.05). Mean change in hemoglobin A1c (%) (-1.75 +/- 5.35; -12.46 to 8.95) and fasting blood glucose (mg/dL) (20.20 +/- 67.87; -115.54 to 155.94) also did not reach statistical significance. Testosterone treatment did not affect fasting lipids, blood pressure, and anthropometric determinations significantly.


CONCLUSIONS
In this study, testosterone treatment showed a neutral effect on insulin resistance and glycemic control and failed to improve dyslipidemia, control blood pressure, or reduce visceral fat significantly in Asian Indian men with T2DM and hypogonadism.
Gopal
Raju A
RA
Department of Endocrinology, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, India. drrajugopal@gmail.com
Bothra
Nikita
N
Acharya
Shrikrishna V
SV
Ganesh
Hosahithlu K
HK
Bandgar
Tushar R
TR
Menon
Padma S
PS
Shah
Nalini S
NS
D000328:Adult; D000728:Androgens / Q000008:administration & dosage / Q000627:therapeutic use*; D044466:Asian People; D001786:Blood Glucose / Q000032:analysis; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications*; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood; D006442:Glycated Hemoglobin / Q000032:analysis; D006706:Homeostasis; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D007194:India; D007273:Injections, Intramuscular; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000008:administration & dosage / Q000627:therapeutic use*
D000728:Androgens; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D006442:Glycated Hemoglobin; D007328:Insulin; D013739:Testosterone; C517652:hemoglobin A1c protein, human