Evaluation of Prealbumin Levels in Men With Low-T

Prealbumin (Transthyretin) Levels in Men With Low-T

This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.

Study Overview

• Status: Completed
• Conditions: Testosterone Deficiency
• Intervention / Treatment: Diagnostic test: Men presenting with low-T

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.

Description

Inclusion Criteria:

• Provide responses to standard questionnaires administered to subjects
• Written Informed Consent obtained
• Male sex at birth
• ≥ 40 and ≤ 75 years of age
• Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
• Able and willing to provide blood specimens and follow study schedule
• A final diagnosis can be established (androgen deficient versus not androgen deficient)

Exclusion Criteria:

• Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
• Use of opioid medication within 3 months prior to enrollment
• Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
• Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
• Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
• Diagnosis of prolactinoma

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men presenting with low-T; Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels.	Diagnostic test: Men presenting with low-T; Evaluation of prealbumin levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prealbumin Levels	Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)	1 day

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2017
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (ACTUAL): October 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Prealbumin
• Other Study ID Numbers: AND-1-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No