Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
2 other identifiers
interventional
24
1 country
1
Brief Summary
The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedDecember 6, 2010
November 1, 2008
7 months
November 5, 2008
December 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fasting plasma glucose
12 weeks
HbA1c (glycosylated hemoglobin)
12 weeks
Secondary Outcomes (5)
Liver enzymes (ALT, AST)
12 weeks
Kidney function (S-creatinine, S-BUN)
12 weeks
Plasma lipids (TG, Cholesterol, HDL-, LDL-)
12 weeks
Blood pressure
12 weeks
Body weight (BMI, hip-waist ratio)
12 weeks
Study Arms (2)
Gynostemma pentaphyllum tea
ACTIVE COMPARATORPlacebo tea
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed, drug-naive patients with type 2 diabetes
- Fasting plasma glucose (FPG) 7.0-14.0 mmol/l
- HbA1c \> 6%
You may not qualify if:
- Type 1 diabetes
- Liver failure
- Kidney Failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanoi Medical Universitylead
- Karolinska Institutetcollaborator
- Swedish International Development Cooperation Agency (SIDA)collaborator
Study Sites (1)
National Institute of Gerontology, HMU
Hanoi, Vietnam
Related Publications (2)
Hoa NK, Norberg A, Sillard R, Van Phan D, Thuan ND, Dzung DT, Jornvall H, Ostenson CG. The possible mechanisms by which phanoside stimulates insulin secretion from rat islets. J Endocrinol. 2007 Feb;192(2):389-94. doi: 10.1677/joe.1.06948.
PMID: 17283239BACKGROUNDNorberg A, Hoa NK, Liepinsh E, Van Phan D, Thuan ND, Jornvall H, Sillard R, Ostenson CG. A novel insulin-releasing substance, phanoside, from the plant Gynostemma pentaphyllum. J Biol Chem. 2004 Oct 1;279(40):41361-7. doi: 10.1074/jbc.M403435200. Epub 2004 Jun 25.
PMID: 15220351BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claes Goran Ostenson, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
February 1, 2007
Primary Completion
September 1, 2007
Study Completion
December 1, 2007
Last Updated
December 6, 2010
Record last verified: 2008-11