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HypogonadismPhase 4TERMSINFATNCT01123278

Testosterone Replacement in Metabolic Syndrome and Inflammation

A Phase 4 study testing Testosterone in people with Hypogonadism and Metabolic Syndrome, run by University of Roma La Sapienza at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Hypogonadism, Metabolic Syndrome, Obesity
What is being tested?
Testosterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
2 sitesItaly
Study dates
Jan 2004to Oct 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with Metabolic Syndrome according to ATPIII
  • patients with mild hypogonadism (both testosterone evaluations between 6 and 11 nmol/L)
  • patients naïve to hypoglycemic therapies

Who cannot join

  • patients on hypoglycemic medications
  • patients with severe hypogonadism (<5 nmol/L)
  • patients with borderline T values hypogonadism (>11 nmol/L)
  • patients with contraindication to testosterone therapy: prostate cancer, PSA>4 ng/ml, severe hepatic or renal insufficiency, Hb>17, Htc>52%, severe urinary retention

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Policlinico Umberto I Hospital - Sapienza University

    Rome, Rome, 00161

  • Dipartimento di Fisiopatologia Medica - Policlinico Umberto I

    Rome, 00161

Other trials in Italy

About this study

Official title: Testosterone Replacement in Metabolic Syndrome and Inflammation of Fat Tissue

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

Read the detailed description

The features of Metabolic Syndrome (MetS) include abdominal obesity, atherogenic dyslipidemia, raised blood pressure, insulin resistance or glucose intolerance. These symptoms are also frequently found in hypogonadal men.

Adipose tissue and androgens in male obesity are reciprocally linked. Total and free testosterone (T) are decreased in proportion to the degree of body fatness while T regulates insulin sensitivity and body composition. As a consequence, hypoandrogenism carries an additional independent risk for cardiovascular and metabolic disorders. Men with type 2 diabetes mellitus (T2D) exhibit lowered T levels that are inversely correlated to HbA1c. In addition, abdominal adiposity causes an impairment of testicular steroidogenesis that is directly linked to circulating adipokines; enhanced cytokine release from macrophage-infiltrated adipose tissue is pivotal to the pathogenesis of insulin resistance and atherosclerosis. Both MetS and T2D share with hypogonadism such a proinflammatory state.

For this reason we performed a randomized controlled trial on the effects of TRT on insulin resistance and circulating inflammatory markers in a cohort of middle-aged men with mild hypogonadism and MetS at first diagnosis, that were not taking medications known to influence the investigated outcomes. We established strict criteria for enrollment and used a physiological replacing therapy.

Given that testosterone replacement therapy (TRT) determines a reduction of body fat mass paralleled by an increase in fat free mass (6), and that TRT exerts an anti-inflammatory role inhibiting interleukins (IL), in particular the IL-6 gene (14), it remains to be established whether these independent effects also reflect in an improvement in insulin resistance.

Being tested
Testosterone, Placebo
Keywords
Adiponectin, Resistin, Adipocytes, Testosterone, Aging, HOMA-IR, Insulin, Hypogonadism, Metabolic Syndrome, Obesity, Erectile Dysfunction
Medical subject headings
Hypogonadism, Metabolic Syndrome, Obesity, Erectile Dysfunction, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TestosteroneDrug

    Also called Androgel, Testogel

    Testosterone transdermal gel 50 mg/day (5 gr)

  • PlaceboDrug

    Placebo transdermal gel (5 gr)

Study groups in NCT01123278
Study groupRoleWhat they receive
Testosterone gelExperimentalTestosterone transdermal gel 50 mg/day
Receives: Drug: Testosterone
Placebo gelPlacebo comparatorPlacebo gel
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat-Free Mass (kg)

    Estimate of within subject absolute change in fat-free mass measured by DEXA (dual energy x-ray absorptiometry) at 3 months (90 days) interval during active or placebo treatment.

    Measured: 3 months

Secondary outcomes (16)

  1. Fat Mass (kg)

    Estimate of within subject absolute change (Kg) in fat mass measured by DEXA at 3 months (90 days) interval during active or placebo treatment.

    Measured: 3 months

  2. HOMA-IR (homeostasis model assessment)- (insulin resistance)

    Estimate of within subject absolute change in measure of insulin resistance homeostatic model HOMA-IR.

    Measured: 3 months

  3. CRP (C reactive protein)

    C reactive protein (High sensitivity).

    Measured: 3 months

  4. Interleukins

    Within subject absolute and percentage change in serum:

    IL-1, IL-6, IL-10, IL-12, IL-2, IL-8, TNFa (tumor necrosis factor alpha)

    Measured: 3 months

  5. Adipokines

    Estimate of within subject absolute change in serum:

    ADIPONECTIN, LEPTIN, RESISTIN.

    Measured: 3 months

  6. Waist circumference

    Waist circumference (cm)

    Measured: 3 months

  7. IIEF

    International Index of Erectile Dysfunction

    Measured: 3 months

  8. Penile CDU (color Doppler ultrasound)

    Penile Color-Doppler Ultrasonography of cavernosal arteries before and after active or placebo treatment.

    Measured: 3 months

  9. PSA (prostatic specific antigen)

    PSA

    Measured: 3 months

  10. Hb, Htc

    haemoglobin and haematocrit

    Measured: 3 months

  11. Fat-free mass

    Measured: 6 months

  12. Fat Mass

    Measured: 6 months

  13. HOMA-IR

    Measured: 6 months

  14. CRP

    Measured: 6 months

  15. Interleukins

    Serum IL-1, IL-6, IL-10, IL-12, IL-2, IL-8, TNFa

    Measured: 6 months

  16. Adipokines

    Serum ADIPONECTIN, LEPTIN, RESISTIN.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2010 (estimated)
  2. Study startJan 2004
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123278
Sponsor's protocol ID
TestoMet05
Acronym
TERMSINFAT
Status last verified
Oct 2014
First submitted
10 May 2010
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Isidori AM, Caprio M, Strollo F, Moretti C, Frajese G, Isidori A, Fabbri A. Leptin and androgens in male obesity: evidence for leptin contribution to reduced androgen levels. J Clin Endocrinol Metab. 1999 Oct;84(10):3673-80. doi: 10.1210/jcem.84.10.6082.

    PubMed 10523013

  • Aversa A, Isidori AM, Greco EA, Giannetta E, Gianfrilli D, Spera E, Fabbri A. Hormonal supplementation and erectile dysfunction. Eur Urol. 2004 May;45(5):535-8. doi: 10.1016/j.eururo.2004.01.005.

    PubMed 15082192

  • Isidori AM, Giannetta E, Pozza C, Bonifacio V, Isidori A. Androgens, cardiovascular disease and osteoporosis. J Endocrinol Invest. 2005;28(10 Suppl):73-9.

    PubMed 16550728

  • Isidori AM, Greco EA, Aversa A. Androgen deficiency and hormone-replacement therapy. BJU Int. 2005 Aug;96(2):212-6. doi: 10.1111/j.1464-410X.2005.05603.x. No abstract available.

    PubMed 16001962

  • Isidori AM, Giannetta E, Greco EA, Gianfrilli D, Bonifacio V, Isidori A, Lenzi A, Fabbri A. Effects of testosterone on body composition, bone metabolism and serum lipid profile in middle-aged men: a meta-analysis. Clin Endocrinol (Oxf). 2005 Sep;63(3):280-93. doi: 10.1111/j.1365-2265.2005.02339.x.

    PubMed 16117815

  • Isidori AM, Giannetta E, Gianfrilli D, Greco EA, Bonifacio V, Aversa A, Isidori A, Fabbri A, Lenzi A. Effects of testosterone on sexual function in men: results of a meta-analysis. Clin Endocrinol (Oxf). 2005 Oct;63(4):381-94. doi: 10.1111/j.1365-2265.2005.02350.x.

    PubMed 16181230

  • Isidori AM, Lenzi A. Testosterone replacement therapy: what we know is not yet enough. Mayo Clin Proc. 2007 Jan;82(1):11-3. doi: 10.4065/82.1.11. No abstract available.

    PubMed 17285780

  • Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf). 2003 May;58(5):632-8. doi: 10.1046/j.1365-2265.2003.01764.x.

    PubMed 12699447

  • Aversa A, Isidori AM, De Martino MU, Caprio M, Fabbrini E, Rocchietti-March M, Frajese G, Fabbri A. Androgens and penile erection: evidence for a direct relationship between free testosterone and cavernous vasodilation in men with erectile dysfunction. Clin Endocrinol (Oxf). 2000 Oct;53(4):517-22. doi: 10.1046/j.1365-2265.2000.01118.x.

    PubMed 11012578

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Testosterone in people with Hypogonadism and Metabolic Syndrome, run by University of Roma La Sapienza at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat-Free Mass (kg) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01123278, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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