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

July 4, 2013 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Whole grains and legumes
Dietary supplement: Dietary intervention-whole grains and legumes
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.
PLACEBO_COMPARATOR: Refined rice
Dietary supplement: Dietary intervention-Refined rice
Subjects in the control group maintained their usual diet of refined rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Lp-PLA2 activity
Time Frame: Change from baseline in Lp-PLA2 at 12 weeks
Change from baseline in Lp-PLA2 at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PBMC Lp-PLA2 activity
Time Frame: Change from baseline in PBMC Lp-PLA2 at 12 weeks
Change from baseline in PBMC Lp-PLA2 at 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
LDL particle size
Time Frame: Change from baseline in LDL particle size at 12 weeks
Change from baseline in LDL particle size at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 4, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FN20130614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impaired Fasting Glucose

Clinical Trials on Dietary intervention-whole grains and legumes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe