Testosterone Deficiency
Conditions
Keywords
Prealbumin
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMen presenting with low-T
Evaluation of prealbumin levels.
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prealbumin Levels | 1 day | Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD) |
Countries
United States
Outcome results
None listed