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OpenTrials
Completed

NCT Number: NCT01895387

Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

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Key information

Conditions

Impaired Fasting Glucose Newly Diagnosed Type 2 Diabetes

Age range

39 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University

Seoul, South Korea

About this study

Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose <126 mg/dL)
  • or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion criteria

  • current and/or past history of cardiovascular disease including angina
  • liver or kidney dysfunction
  • thyroid or pituitary disease
  • unstable weight loss/gain (≥2 kg) over the previous 12 months
  • pregnancy or lactation
  • taking medications or supplements

Treatment and study plan

Dietary intervention-whole grains and legumes

Dietary Supplement

Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.

Dietary intervention-refined rice

Dietary Supplement

Subjects in the control group maintained their usual diet of refined rice

Primary outcomes

  1. Plasma Lp-PLA2 activity

    Time frame: Change from baseline in Lp-PLA2 at 12 weeks

Secondary outcomes

  1. PBMC Lp-PLA2 activity

    Time frame: Change from baseline in PBMC Lp-PLA2 at 12 weeks

Other outcomes

  1. LDL particle size

    Time frame: Change from baseline in LDL particle size at 12 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2013
Registry last updated
Jul 10, 2013

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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