Effect of Hyperglycemia on Gastric Emptying Interactions With Pramlintide

What Was Tested

In this not phased trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

• To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.

It had four arms (groups): 1 (placebo comparator), 2 (experimental), 3 (placebo comparator) and 4 (experimental).

Placebo, euglycemia.

Pramlintide, euglycemia.

Placebo, hyperglycemia.

The registry classes the interventions as drug.

More on the Plan

The latter is predominantly determined by the amount of glucose taken up by the splanchnic bed.

Because nutrient absorption depends on gastric nutrient delivery, gastric emptying rate is a key determinant of the early rise of plasma glucose postprandially.

At mealtime, the faster the stomach empties the more rapid the rise in plasma glucose.

Yet, plasma glucose concentration is a determinant of gastric emptying rate.

Who Took Part

The registry lists 27 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: 20-40 years of age, inclusive. Understand and sign an informed consent document, communicate with the investigator, and understand and comply with the requirements of the study. Euthyroid, including subjects receiving thyroid replacement therapy. Is surgically sterilized by hysterectomy; OR. If of childbearing potential, meets the following criteria:.

The full record lists 9 inclusion and 32 exclusion criteria; among the exclusions: individuals meeting any of the following criteria are to be excluded from the study unless the investigator grants an exception:; history of severe hypoglycemia; body mass index (bmi) ≥ 30 kg/m2.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

In this single-blind Amylin (Islet Amyloid Polypeptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2005-01 with completion listed for 2007-03.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: • To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 27 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 Amylin (Islet Amyloid Polypeptide) compound page, all human trials.