Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes
Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started May 2006
Shorter than P25 for phase_3 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedJune 17, 2008
June 1, 2008
5 months
April 11, 2008
June 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the change of total to HDL cholesterol ratio
12 weeks
Secondary Outcomes (6)
the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)
12 weeks
the change of ox-LDL
12 weeks
the change of fasting plasma glucose
12 weeks
the change of HbA1c
12 weeks
the change of CRP
12 weeks
- +1 more secondary outcomes
Study Arms (1)
A
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- type 2 diabetic subjects
- age between 50 and 75 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
I Te Lee, MD
Taichung Veterans General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2008
First Posted
June 12, 2008
Study Start
May 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
June 17, 2008
Record last verified: 2008-06