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Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2

Plain-language guide to NCT00638209: not phased randomized trial of Insulin (regular human), 42 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00638209
Phase
not phased
Status
status unknown
Start
2008-02
Completion (planned or actual)
2010-05
Participants
42 (estimated)
Design
randomized, single-blind, basic_science
Conditions studied
Human Physiology of Energy Homeostasis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.

It had two arms (groups): I (active comparator) and P (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes).

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: type 2 diabetes pregnancy acute or chronic diseases.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2008-02 with completion listed for 2010-05.

It ran at 2 sites in Germany (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Insulin effect on cortical function (spectral analysis) (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 42 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

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.