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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

Primary Purpose

Impaired Fasting Glucose, Newly Diagnosed Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dietary intervention-whole grains and legumes
Dietary intervention-Refined rice
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impaired Fasting Glucose

Eligibility Criteria

39 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Whole grains and legumes

Refined rice

Arm Description

Outcomes

Primary Outcome Measures

Plasma Lp-PLA2 activity

Secondary Outcome Measures

PBMC Lp-PLA2 activity

Full Information

First Posted
June 14, 2013
Last Updated
July 4, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01895387
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Fasting Glucose, Newly Diagnosed Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole grains and legumes
Arm Type
Experimental
Arm Title
Refined rice
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention-whole grains and legumes
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention-Refined rice
Intervention Description
Subjects in the control group maintained their usual diet of refined rice
Primary Outcome Measure Information:
Title
Plasma Lp-PLA2 activity
Time Frame
Change from baseline in Lp-PLA2 at 12 weeks
Secondary Outcome Measure Information:
Title
PBMC Lp-PLA2 activity
Time Frame
Change from baseline in PBMC Lp-PLA2 at 12 weeks
Other Pre-specified Outcome Measures:
Title
LDL particle size
Time Frame
Change from baseline in LDL particle size at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, Ph.D
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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