← Human Trials & Peer-Reviewed Studies

Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes

Plain-language guide to NCT00168519: not phased randomized trial of AICAR, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00168519
Phase
not phased
Status
completed
Start
2002-10
Completion (planned or actual)
2009-04
Participants
40 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Diabetes Mellitus, Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test AICAR.

It had 1 arm (groups): 1 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Twenty male type 2 diabetic patients aged between 30 and 60 years will be recruited from their clinic and through advertisement.

Verapamil is a calcium channel antagonist which causes vasodilatation by direct actions on the smooth muscle.

A single Vastus lateralis biopsy will be performed as a comparison against type 2 diabetics.

Baseline exhaled nitric oxide (NO) and pulmonary blood flow will be measured in collaboration with Dr Bruce Thompson from the Alfred Respiratory Department.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Free of overt coronary disease (stress ECG). Body mass index \< 35 kg.m-2. Unmedicated (diet controlled). Free of overt coronary disease (ECG). Body mass index \< 30 kg.m-2.

The full record lists 10 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got AICAR and who got the comparison, which limits bias.

Each person switched between AICAR and the comparison at some point, usually with a gap in between.

In this single-blind AICAR study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2002-10 with completion listed for 2009-04.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: glucose metabolism (time frame: 3 hours).

It also tracked 1 secondary outcome, for example .

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of AICAR in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the AICAR compound page, all human trials.

Our Notes on the Compound

AICAR: A research compound that activates AMPK, nicknamed the “exercise pill”; prohibited in sport and not approved for human use.

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.