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T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin (T-IR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Katya Rubinow, University of Washington
ClinicalTrials.gov Identifier:
NCT01686828
First received: September 12, 2012
Last updated: June 12, 2017
Last verified: June 2017
September 12, 2012
June 12, 2017
June 2013
May 2015   (Final data collection date for primary outcome measure)
Insulin Sensitivity Quantified by Matsuda Index [ Time Frame: 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
Insulin sensitivity index [ Time Frame: 4 weeks ]
Glucose disposal assessed by frequently sampled intravenous glucose tolerance test (FG-IGT)
Complete list of historical versions of study NCT01686828 on ClinicalTrials.gov Archive Site
  • Changes in Body Composition [ Time Frame: 4 weeks ]
    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
  • Changes in Adipose Tissue Gene Expression [ Time Frame: 4 weeks ]
    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.
Not Provided
Not Provided
Not Provided
 
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
The investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. This study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. Three drugs will be used in this study: acyline, given by injection; testosterone (T) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). Acyline inhibits the production of luteinizing hormone (LH) and follicle stimulating hormone (FSH). When acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. Adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. One group of men will receive T gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. This design will enable determination of the respective metabolic effects of testosterone and estrogen.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Insulin Resistance
  • Type 2 Diabetes Mellitus
  • Obesity
  • Androgen Deficiency
  • Metabolic Disease
  • Drug: Acyline
    300 mcg/mL administered subcutaneously (at Day 0, Week 2)
  • Drug: Testosterone 1.62% gel
    Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
    Other Name: Androgel
  • Drug: Letrozole
    Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
    Other Name: Femara
  • Drug: Placebo gel (for Testosterone 1.62% gel)
    placebo gel manufactured to mimic Testosterone 1.62% gel
  • Drug: Placebo pill (for Letrozole)
    Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
  • Experimental: Acyline & placebo gel & placebo pill
    Acyline (300mcg/kg) + placebo transdermal gel + placebo pill daily
    Interventions:
    • Drug: Acyline
    • Drug: Placebo gel (for Testosterone 1.62% gel)
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone 1.25g & placebo pill
    Acyline (300mcg/kg) + Testosterone gel (1.25g) daily + placebo pill daily
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone 5g & placebo pill
    Acyline (300mcg/kg) + Testosterone gel (5g) daily + placebo pill daily
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone & Letrozole
    Acyline (300mcg/kg) + Testosterone gel (5g) daily + letrozole (5mg) daily
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Letrozole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53
December 2017
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
25 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01686828
43007
Yes
Not Provided
Plan to Share IPD: Undecided
Katya Rubinow, University of Washington
University of Washington
Not Provided
Study Chair: William J Bremner, MD, PhD University of Washington
Study Director: Stephanie T Page, MD, PhD University of Washington
Principal Investigator: Katya Rubinow, MD University of Washington
University of Washington
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP