Obesity Clinical Trial
— T-IROfficial title:
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men
Verified date | April 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
Status | Completed |
Enrollment | 53 |
Est. completion date | December 2017 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Prostate-specific antigen (PSA) = 3 ng/mL - Age 25-55 years - Ability to understand the study, study procedures and provide informed consent - Serum total T > 300 ng/dL - Normal reproductive history and exam - International Prostate Symptom Score (IPSS) < 11 Exclusion Criteria: - A history of prostate cancer including suspicious digital rectal exam (DRE) or history of highgrade prostatic intraepithelial neoplasia (PIN) on prostate biopsy - Invasive therapy for benign prostatic hyperplasia (BPH) in the past - History of acute urinary retention in the previous 3 months - Current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months) - Current use of statins or glucocorticoids - Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease - A history of or current breast cancer - Known, untreated obstructive sleep apnea - Hematocrit > 50 or < 34 - Hypersensitivity to any of the drugs used in the study - History of a bleeding disorder or anticoagulation - Participation in any other drug study within past 90 days - History of drug or alcohol abuse within the last 12 months - Weight > 280 lbs. or BMI = 33 - Desire for fertility in the next 6 months or current pregnant partner - Sperm concentration <14 million/ml - Significant, uncontrolled hypertension (BP >160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 |
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