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NCT00219440 · ClinicalTrials.gov registry record · Phase 4

A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

A Phase 4 study, sponsored by Pennington Biomedical Research Center.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target

NCT00219440: Completed Phase 4 study, sponsored by Pennington Biomedical Research Center.

NCT00219440 is a Phase 4 study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00219440, a Phase 4 study, has completed, sponsored by Pennington Biomedical Research Center.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target

Study Summary

We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Interventions

  • OTHER Actos plus standard diet
  • OTHER Actos plus structured diet
  • OTHER Metformin plus standard diet

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2003-02
Est. Completion 2006-12
Phase Phase 4

What the finished NCT00219440 record still lists

NCT00219440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 3 interventions - of which Actos plus standard diet is the first listed.

NCT00219440 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00219440 about?

NCT00219440 is a clinical study titled "A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS". We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone a...

What is the current status of trial NCT00219440?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2003-02. Estimated completion is 2006-12.

What interventions are being tested in trial NCT00219440?

The interventions under investigation include: Actos plus standard diet (OTHER), Actos plus structured diet (OTHER), Metformin plus standard diet (OTHER).

Who is sponsoring clinical trial NCT00219440?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00219440's enrollment target sits among peer trials

60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00219440, the US trial registry maintained by the National Library of Medicine. NCT00219440 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.