Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men (T-IR)

NCT01686828 Phase 1/Phase 2 COMPLETED Results posted

The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.

Details

Lead sponsor	University of Washington
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	53
Start date	2013-06
Completion	2017-12

Conditions

• Insulin Resistance
• Type 2 Diabetes Mellitus
• Obesity
• Androgen Deficiency
• Metabolic Disease

Interventions

• Acyline
• Testosterone 1.62% gel
• Letrozole
• Placebo gel (for Testosterone 1.62% gel)
• Placebo pill (for Letrozole)

Primary outcomes

• Insulin Sensitivity Quantified by Matsuda Index — 4 weeks
  Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG\*FI)\*(FPG+PG30\*2+PG60\*2+PG90\*2+PG120)/8\*(FPI+PI30\*2+PI60\*2+PI90\*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after the oral glucose load

Countries

United States