In Vivo Assessment of Cellular Metabolism in Humans

What Was Tested

The trial (phase 1) is built around Glucagon and Somatostatin for cellulite.

This is a pilot study to establish an arterial venous methodology to measure the activity of the TCA cycle or flux directly in tissues of human beings.

It will also perform correlative studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle activity.

It had two arms (groups): Control Group (no intervention) and Intervention Group (active comparator).

No somatostatin and glucagon infusions.

Somatostatin and glucagon infusions.

The registry classes the interventions as drug.

More on the Plan

The tricarboxylic (TCA) or Krebs cycle is the "central hub of cellular metabolism" that takes place within the mitochondria.

It is a series of sequential chemical reactions that generate cellular energy in the form of ATP.

Almost all studies are based on in vitro approaches except NMRS based studies that involve multiple non-validated assumptions.

Various stable isotope labeling studies have been used to estimate the TCA cycle flux by measuring one or more labelled intermediate metabolites within the cycle.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Able to provide written consent.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: renal failure; steroid use; muscle disease.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Glucagon study did not mask who received what.

It started in 2016-07 with completion listed for 2017-03-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: In Vivo TCA cycle flux in skeletal muscle and splanchnic tissue (time frame: 12 hours).

It also tracked 6 secondary outcomes, for example Changes in the metabolome derived from the arterial-venous blood supply of the skeletal muscle and splanchnic tissue, Oxygen consumption in skeletal muscle and splanchnic tissue in response to hormonal manipulation, Mitochondrial respiration in skeletal muscle tissue and Reactive oxygen species emissions in skeletal muscle tissue.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon and Somatostatin in 17 people with cellulite.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page and the Somatostatin compound page, Cellulite research.