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Clinical Trial Details

Trial ID: L6626
Source ID: NCT01686828
Associated Drug: Acyline
Title: T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
Acronym: T-IR
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01686828/results
Conditions: Insulin Resistance|Type 2 Diabetes Mellitus|Obesity|Androgen Deficiency|Metabolic Disease
Interventions: DRUG: Acyline|DRUG: Testosterone 1.62% gel|DRUG: Letrozole|DRUG: Placebo gel (for Testosterone 1.62% gel)|DRUG: Placebo pill (for Letrozole)
Outcome Measures: Primary: Insulin Sensitivity Quantified by Matsuda Index, 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, 4 weeks | Secondary: Changes in Body Composition, Fat mass and lean mass were measured by dual energy X-ray absorptiometry (DEXA) at baseline and at the end of the 4 week treatment period, 4 weeks|Changes in Adipose Tissue Gene Expression, We examined whether differences in lipoprotein lipase expression would be evident across study treatment groups. RNA was isolated from whole adipose tissue gene expression, and complementary DNA (cDNA) was synthesized from 1.5 ug of RNA per sample. Gene expression was measured by polymerase chain reaction (PCR) using predesigned TaqMan® Gene Expression Assays. Standard curves were included on each plate, so Ct values were converted to copy numbers of the target gene. Expression values were normalized to the geometric mean of the housekeeping genes phosphoglycerate kinase and 18s., 4 weeks
Sponsor/Collaborators: Sponsor: University of Washington
Gender: MALE
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 53
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-06
Completion Date: 2017-12
Results First Posted: 2017-06-14
Last Update Posted: 2018-05-08
Locations: University of Washington, Seattle, Washington, 98195, United States
URL: https://clinicaltrials.gov/show/NCT01686828