Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

What Was Tested

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

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Participants will receive treatment with growth hormone releasing hormone 1-44 (TH9507).

Participants will receive treatment with placebo medication.

The registry classes the interventions as drug.

More on the Plan

Obesity, defined as having a high amount of excess body fat, is one of the most wide-spread health problems of today.

A variety of factors can lead to obesity.

These factors include physical inactivity, family history and genetics, metabolism, and hormone imbalance.

People with abdominal obesity, where fat is stored predominantly around a person's midsection, are particularly prone to weight-related diseases.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Body mass index (BMI) greater than or equal to 30 kg/m2. Waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women. Relative growth hormone (GH) deficiency, defined as a peak GH value of less than or equal to 8 ng/mL on Arginine-GHRH stimulation test. Serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase less than 2.5 times the upper limit of normal. Negative mammogram within 1 year of study entry for women older than 40 years of age.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: obesity due to a known secondary cause (e.g., cushing's syndrome, hypothyroidism) or a history of gastric bypass procedure; known hypersensitivity to ghrh 1-44 (th9507); using any weight lowering drugs.

How the Study Was Run

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

The participants were allocated by chance, so the GHRH (Growth Hormone-Releasing Hormone) group and the comparison group should start out alike.

The GHRH (Growth Hormone-Releasing Hormone) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on GHRH (Growth Hormone-Releasing Hormone), so expectations could not easily colour the readings.

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

It started in 2008-07 with completion listed for 2012-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Visceral Adipose Tissue Volume (time frame: Measured at baseline and Months 6 and 12).

It also tracked 5 secondary outcomes, for example Change in Carotid Intima-media Thickness, Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test, Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone and Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 60 people.

The trial is marked completed; 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.