Metabolomics During Testosterone Therapy

NCT01963390 | Completed

• 1 other identifier: 2012P000184
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Testosterone Deficiency

Keywords

Hypogonadism; Testosterone Deficiency

Outcome Measures

Primary Outcomes (2)

• Metabolomics

  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.

  After 4-6 mo of therapy

• Metabolomics

  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.

  Baseline

Secondary Outcomes (8)

• Symptoms of Testosterone Deficiency

  After 4-6mo of T therapy

• Body Composition

  After 4-6mo of T therapy

• Fasting insulin and glucose

  After 4-6mo of T therapy

• Lipid Profile

  After 4-6mo of T therapy

• Symptoms of Testosterone Deficiency

  Baseline

Study Arms (1)

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

Interventions

Testosterone Therapy DRUG

In this observational study we will be enrolling testosterone deficient men who intend to undergo testosterone therapy.

Testosterone therapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Type 1 diabetes
• Use of exogenous testosterone or clomiphene citrate
• Known karyotype abnormalities
• Seizure disorders
• Malignancy

Sponsors & Collaborators

• Men's Health Boston: lead

Study Sites (1)

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (5)

• Cheng S, Rhee EP, Larson MG, Lewis GD, McCabe EL, Shen D, Palma MJ, Roberts LD, Dejam A, Souza AL, Deik AA, Magnusson M, Fox CS, O'Donnell CJ, Vasan RS, Melander O, Clish CB, Gerszten RE, Wang TJ. Metabolite profiling identifies pathways associated with metabolic risk in humans. Circulation. 2012 May 8;125(18):2222-31. doi: 10.1161/CIRCULATIONAHA.111.067827. Epub 2012 Apr 11.

  PMID: 22496159 BACKGROUND

• Wang TJ, Larson MG, Vasan RS, Cheng S, Rhee EP, McCabe E, Lewis GD, Fox CS, Jacques PF, Fernandez C, O'Donnell CJ, Carr SA, Mootha VK, Florez JC, Souza A, Melander O, Clish CB, Gerszten RE. Metabolite profiles and the risk of developing diabetes. Nat Med. 2011 Apr;17(4):448-53. doi: 10.1038/nm.2307. Epub 2011 Mar 20.

  PMID: 21423183 BACKGROUND

• Rhee EP, Cheng S, Larson MG, Walford GA, Lewis GD, McCabe E, Yang E, Farrell L, Fox CS, O'Donnell CJ, Carr SA, Vasan RS, Florez JC, Clish CB, Wang TJ, Gerszten RE. Lipid profiling identifies a triacylglycerol signature of insulin resistance and improves diabetes prediction in humans. J Clin Invest. 2011 Apr;121(4):1402-11. doi: 10.1172/JCI44442. Epub 2011 Mar 14.

  PMID: 21403394 BACKGROUND

• Kapoor D, Goodwin E, Channer KS, Jones TH. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Eur J Endocrinol. 2006 Jun;154(6):899-906. doi: 10.1530/eje.1.02166.

  PMID: 16728551 BACKGROUND

• Heufelder AE, Saad F, Bunck MC, Gooren L. Fifty-two-week treatment with diet and exercise plus transdermal testosterone reverses the metabolic syndrome and improves glycemic control in men with newly diagnosed type 2 diabetes and subnormal plasma testosterone. J Androl. 2009 Nov-Dec;30(6):726-33. doi: 10.2164/jandrol.108.007005. Epub 2009 Jul 3.

  PMID: 19578132 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples obtained for metabolomics

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Abraham Morgentaler, MD

  Men's Health Boston

  PRINCIPAL INVESTIGATOR

• Ravi Kacker, MD

  Men's Health Boston

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 16, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (1)