Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Somatostatin.

Researchers are trying to determine how changes in fasting glucose and free fatty acids (products released from fat) affect insulin secretion.

It had two arms (groups): Elevation of fasting FFA and Glucose (other) and Lowering of fasting FFA and glucose (other).

The registry classes the interventions as drug and other.

More on the Plan

However, proinsulin has a longer half-life (20-30min) than insulin (5min) and, unlike insulin, is not extracted by the liver.

This limitation can only be overcome by direct and simultaneous measurement of insulin and proinsulin secretion.

This experiment will measure in vivo proinsulin clearance so that proinsulin secretion can be calculated in people with differing degrees of glucose tolerance.

Whether short-term alteration of fasting glucose and FFA can alter subsequent prandial glucose metabolism is unknown.

Who Took Part

It was open to people of any sex aged from 25 years up to 65 years.

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

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: use of glucose-lowering agents; for female subjects: positive pregnancy test at the time of enrollment or study; history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2020-02-01 with completion listed for 2021-12-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): First phase of Insulin secretion in response to manipulation of fasting FFA and glucose (time frame: First 120 minutes of study). Second phase of Insulin secretion in response to manipulation of fasting FFA and glucose (time frame: First 120 minutes of study).

It also tracked 2 secondary outcomes, for example proinsulin secretion in response to manipulation of fasting FFA and glucose and proinsulin clearance in response to manipulation of fasting FFA and glucose.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) and Somatostatin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Somatostatin compound page, all human trials.