Metabolomics During Testosterone Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Men's Health Boston
Sponsor:
Collaborators:
Auxilium Pharmaceuticals
Sexual Medicine Society of North America
Information provided by (Responsible Party):
Men's Health Boston
ClinicalTrials.gov Identifier:
NCT01963390
First received: October 13, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

One promising but understudied area in the field of testosterone (T) therapy is its effect on metabolism and the development of type II diabetes. Metabolomics is a powerful research tool that can detect very early signs of metabolic derangement that may lead to metabolic disease. In this observational study, investigators aim to apply metabolomics in order to better understand how T therapy influences metabolism. In a clinical population of outpatient men with T deficiency investigators will perform comprehensive clinical evaluations and also obtain blood for metabolomics. This will be done once prior to T therapy and again after 4-6 months of T therapy. Investigators hypothesize that they can detect metabolic derangements in men with T deficiency and that these derangements will improve with T therapy.


Condition Intervention
Testosterone Deficiency
Drug: Testosterone Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Testosterone Therapy and Its Effects on Metabolic Function

Resource links provided by NLM:


Further study details as provided by Men's Health Boston:

Primary Outcome Measures:
  • Metabolomics [ Time Frame: After 4-6 mo of therapy ] [ Designated as safety issue: No ]
    Blood samples will be sent to the Metabolite Profiling Platform at the Broad Institute of Harvard/Massachusetts Institute of Technology. Metabolomics measures hundreds of unique chemical markers (metabolites) involved in normal and diseased cellular processes from a blood sample. These metabolites include branched chain and aromatic amino acids, ketoacids, and triacylglycerides.

  • Metabolomics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Blood samples will be sent to the Metabolite Profiling Platform at the Broad Institute of Harvard/Massachusetts Institute of Technology. Metabolomics measures hundreds of unique chemical markers (metabolites) involved in normal and diseased cellular processes from a blood sample. These metabolites include branched chain and aromatic amino acids, ketoacids, and triacylglycerides.


Secondary Outcome Measures:
  • Symptoms of Testosterone Deficiency [ Time Frame: After 4-6mo of T therapy ] [ Designated as safety issue: No ]
    Symptoms of T deficiency will be assessed using the clinical history and using validated and other questionnaires.

  • Body Composition [ Time Frame: After 4-6mo of T therapy ] [ Designated as safety issue: No ]
    Body composition, including visceral and subcutaneous adiposity, will be determined using dual energy x-ray absorptiometry (DXA)

  • Fasting insulin and glucose [ Time Frame: After 4-6mo of T therapy ] [ Designated as safety issue: No ]
    Insulin and glucose will be determined from a fasting blood sample.

  • Lipid Profile [ Time Frame: After 4-6mo of T therapy ] [ Designated as safety issue: No ]
    A clinical lipid profile including LDL, HDL, and total triglycerides will be obtained from a fasting blood sample.

  • Symptoms of Testosterone Deficiency [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Symptoms of T deficiency will be assessed using the clinical history and using validated and other questionnaires.

  • Body Composition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Body composition, including visceral and subcutaneous adiposity, will be determined using dual energy x-ray absorptiometry (DXA)

  • Fasting insulin and glucose [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Insulin and glucose will be determined from a fasting blood sample.

  • Lipid Profile [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A clinical lipid profile including LDL, HDL, and total triglycerides will be obtained from a fasting blood sample.


Biospecimen Retention:   Samples Without DNA

Serum samples obtained for metabolomics


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Testosterone therapy
The study population is a cohort of testosterone deficient men who are planning on undergoing testosterone therapy at an outpatient men's health clinic.
Drug: Testosterone Therapy
In this observational study we will be enrolling testosterone deficient men who intend to undergo testosterone therapy.

Detailed Description:

One promising but understudied area in the field of T therapy is its effect on insulin resistance (IR) and the development of type II diabetes and cardiometabolic disease. Although several clinical studies suggest T therapy improves metabolic parameters and may prevent disease progression, a mechanism for understanding this process is lacking. Investigators propose to use metabolomics to shed light on how metabolic function changes with T therapy.

Metabolomics is an established investigative tool that measures hundreds of unique chemical markers (metabolites) involved in normal and diseased cellular processes from a blood sample. Previous studies using the Metabolite Profiling Platform at the Broad Institute of Harvard/Massachusetts Institute of Technology applied tandem liquid chromatography-mass spectrometry (LC-MS)-based metabolomics to large, population-based cohorts. These studies identified and validated highly sensitive signatures of IR that successfully predicted occult risk for type II diabetes in clinically normal men. Investigators now plan to apply metabolomics to a clinical population in order to obtain a new perspective on the biochemical metabolic changes that occur based on a man's testosterone status. Investigators plan to study men with symptomatic testosterone deficiency identified at Men's Health Boston (MHB), an outpatient men's health clinic.

In a pilot study involving 32 blood samples, investigators have already identified a specific metabolomic signature in men undergoing androgen deprivation therapy for prostate cancer. Based on these preliminary results and other recent studies, investigators hypothesize that they can detect metabolic derangements in men with T deficiency and that these derangements will respond to changes in T levels. Investigators will address this hypothesis though the following specific aims:

Aim 1: To characterize metabolite profiles and evaluate metabolic dysfunction in T deficient men

To accomplish this aim investigators will study T deficient men presenting to MHB. In addition to metabolite profiling, these men will undergo a comprehensive clinical evaluation at MHB including:

  • Complete History and Physical exam
  • Assessment of symptoms of T deficiency and sexual function using validated and other questionnaires
  • Comprehensive hormonal and metabolic laboratory evaluation
  • Body composition (including visceral and subcutaneous adiposity) by dual x-ray absorptiometry (DXA) Investigators will build a reference dataset relating metabolite profiles with metabolic risk factors in a clinical population of T deficient men. This will include data on the relationship between metabolite profiles and sexual and other symptoms of T deficiency. Investigators will also compare concentrations of select metabolites between T deficient men and matched eugonadal controls previously studied in the Framingham cohort.

Aim 2: To determine how T therapy influences metabolite profiles and IR

  1. To identify metabolites that change in response to raising serum T
  2. To determine how changes in metabolite profiles relate to changes in IR
  3. To determine how response in terms of sexual function symptoms of low T relate to response in metabolite profiles and IR.

Metabolite profiles will be obtained and clinical evaluation performed (described above under Aim1) at baseline and again after 6 months of therapy. Investigators will study interactions between changes in sexual function and serum T, IR, body composition and metabolite profiles (with particular attention to established metabolite markers of IR).

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Testosterone deficient men who intend to undergo testosterone therapy at an outpatient men's health clinic.

Criteria

Inclusion Criteria:

  • Symptomatic testosterone deficiency
  • Intend to undergo testosterone therapy at Men's Health Boston
  • Total testosterone <350ng/dL or free testosterone <1.5ng/dL

Exclusion Criteria:

  • Type 1 diabetes
  • Use of exogenous testosterone or clomiphene citrate
  • Known karyotype abnormalities
  • Seizure disorders
  • Malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963390

Contacts
Contact: Anthony Villanova (617) 277 5000 tony@menshealthboston.com
Contact: Ravi Kacker, MD (617) 277 5000 dr.kacker@menshealthboston.com

Locations
United States, Massachusetts
Men's Health Boston Recruiting
Brookline, Massachusetts, United States, 02445
Contact: Anthony Villanova    617-277-5000    tony@menshealthboston.com   
Contact: Ravi Kacker, MD    (617) 277 5000    dr.kacker@menshealthboston.com   
Principal Investigator: Abraham Morgentaler, MD         
Sub-Investigator: Ravi Kacker, MD         
Sub-Investigator: William Conners, MD         
Sub-Investigator: Anthony Villanova         
Sponsors and Collaborators
Men's Health Boston
Auxilium Pharmaceuticals
Sexual Medicine Society of North America
Investigators
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
Study Director: Ravi Kacker, MD Men's Health Boston
  More Information

Publications:

Responsible Party: Men's Health Boston
ClinicalTrials.gov Identifier: NCT01963390     History of Changes
Other Study ID Numbers: 2012P000184
Study First Received: October 13, 2013
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Men's Health Boston:
Hypogonadism
Testosterone Deficiency

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 02, 2014