The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

The purpose of the study is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia.

Moreover the researchers wish to assess the effect of acute hyperglycemia on cardiac output.

It had two arms (groups): Euglycemic (experimental) and Hyperglycemic (experimental).

The registry classes the interventions as drug.

More on the Plan

Obesity, diabetes and the metabolic syndrome are the main risk factors for cardiovascular disease.

People with type 2 diabetes and no history of heart disease have a risk of myocardial infarction similar to the risk in non-diabetic patients with known heart disease.

However, the causal relationship between obesity, diabetes and cardiovascular disease is unclear.

Insulin resistance leads to many metabolic abnormalities, including high circulating levels of free fatty acids (FFA).

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Age 40-75 years old. BMI between 22 and 35. Type 2 diabetes treated with insulin (\< 60 IE/day).

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: severe disease; severe cardiac disease.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2008-03 with completion listed for 2010-11.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Metabolic changes (time frame: 6 hours).

It also tracked 1 secondary outcome, for example Left ventricular function.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 18 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.