Acetyl-L-Carnitine in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested L-Carnitine.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Statin and acetyl-L-carnitine.

Statin and placebo.

The registry classes the interventions as drug.

More on the Plan

Thus, availability of drugs that may help controlling systolic hypertension without appreciably affecting diastolic blood pressure would have major clinical implications.

In addition to arterial hypertension, dyslipidemia is also a component of the metabolic syndrome that is almost invariably observed in people with type 2 diabetes and remarkably contributes to the excess cardiovascular risk in this population.

Whether amelioration of insulin resistance may explain at least in part this effect is unclear.

C.To monitor systolic/diastolic blood pressure and other clinical/laboratory parameters evaluated during the study two months after Acetyl-L-Carnitine therapy or Placebo withdrawal in patients completing the study and maintained on the same background medications.

Who Took Part

The registry lists 229 actual participants took part.

It was open to people of any sex aged from 40 years up to 85 years.

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

Examples of who could join: Males and females \>40 years old;. High-risk subjects with type 2 diabetes (WHO criteria);. High blood pressure (systolic blood pressure \>140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months);. Patients legally able to give written informed consent to the trial (signed and dated by the patient);. Written informed consent.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: acute cardiovascular events over the last 3 months;; specific contraindications or history of hypersensitivity to the study drugs;; previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

The L-Carnitine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-04 with completion listed for 2012-05.

It ran at 5 sites in Italy (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Arterial blood pressure and dyslipidemia (time frame: Basal, 15th day, 30th day, 3rd and 6th month).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 229 people.

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

More context: the L-Carnitine compound page, all human trials.