Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla

What Was Tested

In this phase 2 trial, researchers set out to test Somatostatin.

The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.

The researchers will measure brain glycogen turnover and content in normal controls and subjects with diabetes under conditions of modest hyper-and hypoglycemia.

It had two arms (groups): somatostatin (experimental) and 2 (no intervention).

Type 1 diabetes and Hypoglycemia unawareness.

Healthy control subjects.

The registry classes the interventions as drug.

More on the Plan

On the morning before the study subjects will report to the Clinical Research Center and will be asked to stay at the Clinical Research Center for up to 72 hours.

You will be asked not to eat anything after midnight.

Small plastic catheters will be placed in two veins in subjects arms for infusion of glucose and for measuring blood glucose levels every 15-30 minutes.

A nurse will stay with the subject at all times during this study.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Must be able to provide informed consent.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: over 300 pounds; history of ischemic heart disease, arrhythmia, of seizure disorder; on medications known to alter blood flow or carbohydrate metabolism.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Somatostatin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2004-12 with completion listed for 2017-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Brain Glycogen Turnover Rate (time frame: 1 month).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Somatostatin in 10 people.

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 Somatostatin compound page, all human trials.