Evaluation of Prealbumin Levels in Men With Low-T

NCT ID: NCT03313635

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-08

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Testosterone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men presenting with low-T

Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels.

Men presenting with low-T

Intervention Type DIAGNOSTIC_TEST

Evaluation of prealbumin levels.

Interventions

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Men presenting with low-T

Evaluation of prealbumin levels.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Morgentaler, MD

Role: PRINCIPAL_INVESTIGATOR

Men's Health Boston

Locations

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Men's Health Boston

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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AND-1-17

Identifier Type: -

Identifier Source: org_study_id

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