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NCT01895387 Clinical 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

Impaired Fasting Glucose Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01895387
Other study ID # FN20130614
Secondary ID
Status Completed
Phase N/A
First received June 14, 2013
Last updated July 4, 2013
Start date January 2012
Est. completion date October 2012

Study information
Verified date July 2013
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 39 Years to 74 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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.
• Dietary intervention-Refined rice
Subjects in the control group maintained their usual diet of refined rice

Locations
Country Name City State
Korea, Republic of Yonsei University Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other LDL particle size Change from baseline in LDL particle size at 12 weeks Yes
Primary Plasma Lp-PLA2 activity Change from baseline in Lp-PLA2 at 12 weeks Yes
Secondary PBMC Lp-PLA2 activity Change from baseline in PBMC Lp-PLA2 at 12 weeks Yes
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