University at Buffalo Rövid összefoglaló The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity.
The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.
Ideiglenesen le vagy tiltva
Részletes leírás Hypogonadotropic hypogonadism HH occurs in approximately one-third of obese and type 2 diabetic men.
Considering that there are 24 million diabetic and million obese people, of which half are males, obesity and type 2 diabetes potentially constitute the major cause of hypogonadism in the population.
We hypothesize that 1 HH in obese and type 2 diabetic men is associated with decreased insulin sensitivity, increased fat tissue mass, decreased lean body mass, increased inflammatory and oxidative stress, impaired sexual function and depressed mood as compared to diabetic and obese men with normal testosterone concentrations; and that 2 testosterone replacement for 24 weeks in men with HH leads to an improvement in these parameters.
Our proposed study would be the first prospective, does low testosterone cause prostate cancer trial to comprehensively evaluate the effect of Fokozott vizelés on insulin sensitivity, body composition, inflammatory and oxidative indices in obese and type 2 diabetic subjects and the effect of six months of T replacement on these parameters.
The study will have 2 arms obese and type 2 diabetic arm with subjects in Diabetes arm and 80 subjects in obese arm.
Half of men in each arm will have HH and half men will have normal testosterone concentrations eugonadal men. Insulin sensitivity will be assessed by hyperinsulinemic-euglycemic clamps. All subjects will undergo hyperinsulinemic-euglycemic clamp, MRI, DEXA and give blood and urine samples for measurement of inflammatory and oxidative stress at baseline.
Men with HH will then be randomized to receive testosterone or placebo gel for a total of 24 weeks. These men will undergo hyperinsulinemic-euglycemic clamps and give blood and urine samples for inflammation and oxidative stress at 4 weeks and 24 weeks.
The primary endpoint of the study is to define a difference in whole body glucose uptake during hyperinsulinemic-euglycemic clamps between hypogonadal and eugonadal diabetes patients at baseline and an increase in glucose uptake in HH subjects after treatment with testosterone for 24 weeks. Therefore there will be 60 men with HH in each arm in diabetes group.
Közelgő klinikai vizsgálatok
For baseline comparisons, 60 men with normal testosterone concentrations will also be needed in each arm. We will recruit 40 obese patients in each arm.
Thus there will be diabetic men and 80 obese men in the study. Átfogó állapot.