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

What Was Tested

This registered phase 2 trial tested 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): Growth Hormone Releasing Hormone (GHRH) (experimental).

Drug: GHRH.

The registry classes the interventions as drug.

More on the Plan

There are many potential causes of sarcopenia and functional impairment in the elderly, including medical conditions such as cardiovascular disease, altered mood, and sedentary lifestyle.

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 1 (IGF-1) produced systemically by the liver or locally in tissues in response to GH stimulation.

IGF-1, in turn, regulates GH secretion by negative feedback mechanisms at the pituitary gland.

Who Took Part

13 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: Age of 65 years or older. Fasting IGF-1 level \<135ng/ml. BMI 23-40 kg/m2. Capable of giving informed consent.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: diabetes mellitus or use of hypoglycemic agents; known coronary artery disease; liver disease, abnormal liver function tests (lrts\>2x upper limit of normal) or inflammatory bowel disease.

How the Study Was Run

Design: 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 2011-05 with completion listed for 2011-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Muscle Strength (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Glucose Homeostasis, Fat-free and Lean Mass, Fuel Utilization, Physical Performance and Tolerability of Nocturnal Administration.

What This Means in Plain Language

Put simply, this is a phase 2 trial of GHRH (Growth Hormone-Releasing Hormone) in 13 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.