Back to resultsT-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin (T-IR)
Primary Purpose
Insulin Resistance, Type 2 Diabetes Mellitus, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acyline
Testosterone 1.62% gel
Letrozole
Placebo gel (for Testosterone 1.62% gel)
Placebo pill (for Letrozole)
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring insulin, androgens, insulin resistance, testosterone, estradiol, obesity
Eligibility Criteria
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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Acyline & placebo gel & placebo pill
Acyline & Testosterone 1.25g & placebo pill
Acyline & Testosterone 5g & placebo pill
Acyline & Testosterone & Letrozole
Arm Description
Acyline (300mcg/kg) + placebo transdermal gel + placebo pill daily
Acyline (300mcg/kg) + Testosterone gel (1.25g) daily + placebo pill daily
Acyline (300mcg/kg) + Testosterone gel (5g) daily + placebo pill daily
Acyline (300mcg/kg) + Testosterone gel (5g) daily + letrozole (5mg) daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01686828
First Posted
September 12, 2012
Last Updated
April 5, 2018
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT01686828
Brief Title
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
Acronym
T-IR
Official Title
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Type 2 Diabetes Mellitus, Obesity, Androgen Deficiency, Metabolic Disease
Keywords
insulin, androgens, insulin resistance, testosterone, estradiol, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acyline & placebo gel & placebo pill
Arm Type
Experimental
Arm Description
Acyline (300mcg/kg) + placebo transdermal gel + placebo pill daily
Arm Title
Acyline & Testosterone 1.25g & placebo pill
Arm Type
Experimental
Arm Description
Acyline (300mcg/kg) + Testosterone gel (1.25g) daily + placebo pill daily
Arm Title
Acyline & Testosterone 5g & placebo pill
Arm Type
Experimental
Arm Description
Acyline (300mcg/kg) + Testosterone gel (5g) daily + placebo pill daily
Arm Title
Acyline & Testosterone & Letrozole
Arm Type
Experimental
Arm Description
Acyline (300mcg/kg) + Testosterone gel (5g) daily + letrozole (5mg) daily
Intervention Type
Drug
Intervention Name(s)
Acyline
Intervention Description
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Intervention Type
Drug
Intervention Name(s)
Testosterone 1.62% gel
Other Intervention Name(s)
Androgel
Intervention Description
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo gel (for Testosterone 1.62% gel)
Intervention Description
placebo gel manufactured to mimic Testosterone 1.62% gel
Intervention Type
Drug
Intervention Name(s)
Placebo pill (for Letrozole)
Intervention Description
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
Primary Outcome Measure Information:
Title
Insulin Sensitivity Quantified by Matsuda Index
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in Body Composition
Description
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
Time Frame
4 weeks
Title
Changes in Adipose Tissue Gene Expression
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Bremner, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephanie T Page, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katya Rubinow, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Links:
URL
http://depts.washington.edu/popctr/
Description
Dedicated to basic and clinical research focused primarily on the male reproductive system.
Learn more about this trial
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
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