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OpenTrials
Completed

NCT Number: NCT00219440

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 and a portion-controlled diet and metformin with a standard diet.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pennington Center

Baton Rouge, Louisiana, 70808, United States

About this study

A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial

  • ACTOS plus a standard diet
  • ACTOS plus a portion-controlled diet
  • Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion criteria

  • Individuals with co-existing other diseases

Treatment and study plan

Actos plus standard diet

Other

Actos plus standard diet

Actos plus structured diet

Other

Actos plus structured diet

Metformin plus standard diet

Other

Metformin plus standard diet

Primary outcomes

  1. glucose

    Time frame: 4 months

Secondary outcomes

  1. Change in lipids

    Time frame: 4 months

  2. blood pressure

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: TAKE II

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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