Clinical trial NCT00695526: Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes
Official title: Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: cranberry
total to HDL cholesterol ratio
type 2 diabetes
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the change of total to HDL cholesterol ratio
timeFrame: 12 weeks
Secondary outcomes:
measure: the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)
timeFrame: 12 weeks
measure: the change of ox-LDL
timeFrame: 12 weeks
measure: the change of fasting plasma glucose
timeFrame: 12 weeks
measure: the change of HbA1c
timeFrame: 12 weeks
measure: the change of CRP
timeFrame: 12 weeks
measure: the change of UAE
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I Te Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: