Subjects With Mild Hypertriglyceridemia in Type 2 DM
Conditions
Brief summary
We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.
Detailed description
We genotyped the APOA5 -1131T\>C in individuals with impaired fasting glucose (IFG) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.
Interventions
DIETARY_SUPPLEMENTDietary intervention
The intervention program consisted of replacing of refined rice intake with 1/3 of legumes, 1/3 of barleys, and 1/3 of whole grains three times per day as a high carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake. The subjects were recommended to drink no more than one alcoholic beverage drink (15 g alcohol) per day and were assigned physical activity consisting of a regular 30-min walk after dinner each day. Participants were also instructed to record their physical activity diary for 24 h every 4 weeks.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL) were referred to the Department of Family Medicine or Internal Medicine. They were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program
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 6months * Pregnancy or lactation. Subjects who were taking medication were also excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride | change from baseline in TG at 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Apolipoprotein A5 | Change from baseline in ApoA5 at 12 weeks |
Other
| Measure | Time frame |
|---|---|
| Apolipoprotein A5 gene | ApoA5 -1131T>C polymorphism |
Countries
South Korea
Outcome results
None listed