Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

What Was Tested

The trial (phase 2) is built around L-Carnitine for insulin resistance, prediabetes & type 2 diabetes.

The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.

It had two arms (groups): Glucose solution (active comparator) and Glucose and L-carnitine solution (experimental).

The registry classes the interventions as drug.

Who Took Part

35 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥18 years. Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months. Have not experienced peritonitis episodes in the last 3 months. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month. Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit.

The full record lists 13 inclusion and 12 exclusion criteria; among the exclusions: have a history of drug or alcohol abuse in the six months prior to entering the protocol; be in treatment with androgens; have diabetes mellitus (as defined by the american diabetes society, objectively documented by a fasting plasma glucose and hba1c determinations).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the L-Carnitine study did not mask who received what.

It started in 2008-01 with completion listed for 2012-09.

It ran at 12 sites in Italy (12).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 35 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 L-Carnitine compound page, Insulin resistance, prediabetes & type 2 diabetes research.