Insulin Resistance and Testosterone in Women

What Was Tested

The trial (phase 2) is built around Leuprolide for insulin resistance, prediabetes & type 2 diabetes.

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

Metformin pill plus placebo injection.

Leuprolide injection plus placebo pill.

Placebo pill plus placebo injection.

The registry classes the interventions as drug.

More on the Plan

Participation will include five visits, each lasting on average 2.5 hours, over a period of 13-20 weeks.

At the screening visit, the participant's medical history, current use of medications and dietary supplements, and social habits will be recorded.

This information will be reviewed on each subsequent visit; participants are asked to maintain their current diet and physical activity level throughout the study.

A brief physical exam will be performed, and blood will be drawn.

Who Took Part

The registry lists 35 actual participants took part.

It was open to women only aged from 50 years up to 79 years.

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

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: history of cancer requiring treatment within the past 5 years (exceptions may be made by investigator); hospitalization for treatment of vascular disease in the past 6 months; uncontrolled hypertension.

How the Study Was Run

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

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

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

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

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

It started in 2005-07 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Free Testosterone (T) (time frame: Baseline to 12 weeks). Change in Insulin Sensitivity (time frame: baseline and 12 weeks).

It also tracked 7 secondary outcomes, for example Percent Change in Luteinizing Hormone (LH) From Baseline, Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR), Percent Change in Low Density Lipoprotein (LDL), Percent Change in Systolic Blood Pressure, Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent and Dehydroepiandrosterone Sulfate (DHEA-S).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 35 people with insulin resistance, prediabetes & type 2 diabetes.

Its size is small, so on its own it can only give an early look.

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

More context: the Leuprolide compound page, Insulin resistance, prediabetes & type 2 diabetes research.