The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production

What Was Tested

The trial (phase 2, phase 3) is built around Insulin (regular human).

This study compares the effect of insulin given as a nasal spray with a placebo.

Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut.

It had two arms (groups): Insulin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In study B they will receive placebo.

On the day of the study subjects will drink regular liquid nutrient formula to maintain a constant fed state.

A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) will be started at 7am.

From 9am a regular infusion of a stable isotope tracer will be started together with nasal spray of either insulin/placebo.

Who Took Part

The registry lists 9 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women, aged 18 to 60 years. Body mass index 20 to 40 kg/m2. Hemoglobin in the normal range. Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: study participant with a history of hepatitis/hepatic disease that has been active within the previous two years; any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis; any current or previous history of endocrine disease, dyslipidemia or malignancy.

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-04-14 with completion listed for 2017-02-15.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Triglyceride-rich lipoprotein apolipoprotein B100 production rate (time frame: 10 hours).

It also tracked 1 secondary outcome, for example Triglyceride-rich lipoprotein apolipoprotein B48 production rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin (regular human) in 9 people.

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 Insulin (regular human) compound page, all human trials.