Type 2 Diabetes
Conditions
Keywords
cranberry, total to HDL cholesterol ratio, type 2 diabetes
Brief summary
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.
Detailed description
Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.
Interventions
DIETARY_SUPPLEMENTcranberry
cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetic subjects * age between 50 and 75 years
Exclusion criteria
* glycosylated hemoglobin (HbA1c) less than 7% or more than 10%; * triglyceride more than 4.5 mmol/L; * current insulin treatment; * change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks; * abnormal renal function (serum creatinine \> 177 μmol/L; * abnormal liver function test results (more than two-fold upper limit of normal range); * severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease; * smoking in recent 1 year; * alcoholism (more than two drinks daily); * using steroid or drugs with unknown components; * pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change of total to HDL cholesterol ratio | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| the change of ox-LDL | 12 weeks |
| the change of fasting plasma glucose | 12 weeks |
| the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride) | 12 weeks |
| the change of CRP | 12 weeks |
| the change of UAE | 12 weeks |
| the change of HbA1c | 12 weeks |
Countries
Taiwan
Outcome results
None listed