Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

What Was Tested

In this phase 2 trial, researchers set out to test GHRH (Growth Hormone-Releasing Hormone).

The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body.

GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones.

Many elderly people have low levels of GH.

It had 1 arm (groups): GHRH (experimental).

Growth Hormone-Releasing Hormone.

The registry classes the interventions as drug.

More on the Plan

Growth hormone (GH) is a major anabolic hormone that exerts important stimulatory effects on protein synthesis.

Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor I (IGF-I), produced systemically by the liver or locally in tissues in response to GH stimulation.

IGF-I in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 65 years up to 85 years.

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

Examples of who could join: Documentation of low GH levels as assessed by a fasting IGF-1 level \<135ng/ml. Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40 kg/m2).

The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: known coronary artery disease; liver, peptic or inflammatory bowel disease. renal or hematologic disease; elevated prostate specific antigen (psa) (4ng/ml).

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label GHRH (Growth Hormone-Releasing Hormone) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-12-17 with completion listed for 2010-04-29.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Lean Body Mas (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 2 trial of GHRH (Growth Hormone-Releasing Hormone) in 5 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.