Testosterone Effects on Men With the Metabolic Syndrome

What Was Tested

The trial (phase 2) is built around Goserelin.

The metabolic syndrome is a medical condition defined by high levels of cholesterol in the blood, high blood pressure, central obesity (gain in fat around the region of the stomach), and insulin resistance (body responds less well to insulin).

This state of impaired insulin resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic disorders in the U.S.

The registry classes the interventions as drug.

More on the Plan

This protocol will address the impact of three months of testosterone (T) therapy on all components of the metabolic syndrome and the mechanism underlying changes in insulin sensitivity by analyzing changes in body composition, and detailed studies of fat metabolism and skeletal muscle.

In addition, this protocol will address the role of estradiol (E2) in mediating the effect of testosterone on insulin sensitivity.

Seventy-two subjects will undergo a screening visit to assess eligibility after which a baseline evaluation will be performed.

Subjects will then be randomized to one of three 12-week treatment arms, 1) Group 1 (Placebo); 2) Group 2 (Depot GnRH agonist (Zoladex) + T + placebo); or 3) Group 3 (Zoladex + T + aromatase inhibitor (anastrozole)).

Who Took Part

Enrollment: 72 planned participants were the target.

It was open to men only aged from 50 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 50-75 yr. Waist circumference \> 102 cm. Blood pressure \> 130 mm Hg systolic or 85 mm Hg diastolic, or treatment with anti-hypertensives. Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs). Normal TSH, prolactin and prostate specific antigen (PSA) levels (\<2.5 ng/mL).

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: history of testicular disorders (i.e. cryptorchidism); history of prostate cancer; history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Goserelin group and the comparison group ran side by side rather than switching.

As a double-blind Goserelin study, the assignments were hidden from both participants and investigators until the end.

It started in 2006-05 with completion listed for 2011-03.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: insulin sensitivity. muscle and body fat distribution. VO2 max.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 72 people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.