← Human Trials & Peer-Reviewed Studies
Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Plain-language guide to NCT00755404: phase 2 randomized trial of L-Carnitine. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00755404
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2007-06
- Completion (planned or actual)
- 2013-10
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- End Stage Renal Disease; Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested L-Carnitine.
The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.
It had two arms (groups): A (active comparator) and B (experimental).
The registry classes the interventions as drug.
Who 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 3 months that should be confirmed at Baseline Visit.
The full record lists 14 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 acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2007-06 with completion listed for 2013-10.
It ran at 8 sites in Italy (8).
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 people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
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.