Prevention of Obesity in Women Via Estradiol Regulation

What Was Tested

The trial (phase 3) is built around Leuprolide.

The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women.

It had four arms (groups): 1 (placebo comparator), 2 (active comparator), 3 (experimental) and 4 (experimental).

GnRH agonist + placebo.

GnRH agonist + placebo + exercise.

GnRH agonist + Estradiol.

The registry classes the interventions as behavioral and drug.

More on the Plan

Many factors contribute to the current epidemic of obesity.

However, this does not negate the importance of learning the mechanisms by which E2 influences energy balance and fat patterning.

This study uses gonadotropin releasing hormone (GnRH) analog therapy to determine the effects of chronic (5-month) sex hormone suppression on resting energy expenditure (REE), altered hypothalamic-pituitary-adrenal (HPA) axis activity, and fat gain.

It is also hypothesized that stress-induced hypothalamic-pituitary-adrenal (HPA)axis activity will be amplified during sex hormone suppression; altered HPA axis activity leading to cortisol excess causes abdominal fat accumulation.

Who Took Part

The registry lists 79 actual participants took part.

It was open to women only aged from 18 years up to 49 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy premenopausal women, aged 18 to 49 years. Regular menses (no missed cycles in previous year; cycle length 25-35 days). Positive luteinizing hormone test or a mid-luteal serum progesterone greater than 3 ng/mL. Willing to receive all study interventions. Physically able and willing to be randomized to participate in a supervised resistance exercise training program.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: already performing high-intensity resistance exercise training more than 1 day per week; on diabetes medications; use of hormonal contraception in the past 3 months.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2008-05 with completion listed for 2014-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Resting Energy Expenditure (REE) (time frame: Before and after 5 months of treatment). Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression (time frame: Before and after 5 months of treatment).

It also tracked 3 secondary outcomes, for example Total Energy Expenditure (TEE), Fat Mass and Fat-free Mass.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 79 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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