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Severe Insulin Resistance in Patients With Type 2 Diabetes

Plain-language guide to NCT00654056: not phased randomized trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00654056
Phase
not phased
Status
completed
Start
2008-03
Completion (planned or actual)
2009-10
Participants
8 (actual)
Design
randomized, single-blind, basic_science
Conditions studied
Type 2 Diabetes Mellitus
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

It had four arms (groups): L1 (experimental), L2 (experimental), H1 (experimental) and H2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes.

The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus.

According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate.

It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 25 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 25-75 years old. BMI between 25 and 42.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: severe diseases.

How the Study Was Run

Design: randomized, single-group and single-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Only one side, usually the insulin resistance, prediabetes & type 2 diabetes participants, was kept unaware of whether Insulin (regular human) was given.

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

Those kept unaware of assignments: participant.

It started in 2008-03 with completion listed for 2009-10.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Insulin sensitivity (time frame: 8 hours).

It also tracked 1 secondary outcome, for example Changes in insulin signaling proteins?.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 8 people with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.