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

Not Applicable

Completed

• Conditions: Impaired Fasting Glucose; Newly Diagnosed Type 2 Diabetes
• Interventions: Dietary Supplement: Dietary intervention-whole grains and legumes; Dietary Supplement: Dietary intervention-Refined rice

• Registration Number: NCT01895387
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Study First Submitted: 2013-06-14
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-04
• Last Update Submitted: 2013-07-04
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole grains and legumes	Dietary intervention-whole grains and legumes	-
Refined rice	Dietary intervention-Refined rice	-

Primary Outcome Measures

Name	Time	Method
Plasma Lp-PLA2 activity	Change from baseline in Lp-PLA2 at 12 weeks

Secondary Outcome Measures

Name	Time	Method
PBMC Lp-PLA2 activity	Change from baseline in PBMC Lp-PLA2 at 12 weeks

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of