NCT00808860

Brief Summary

The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
Last Updated

December 6, 2010

Status Verified

December 1, 2008

Enrollment Period

8 months

First QC Date

December 15, 2008

Last Update Submit

December 3, 2010

Conditions

Type 2 Diabetes

Keywords

Herbal medicineType 2 diabetesGynostemma pentaphyllum TeaInsulin sensitivityadd-on

Outcome Measures

Primary Outcomes (2)

  • fasting plasma glucose

    12 weeks

  • HbA1C (glycosylated hemoglobin)

    12 weeks

Secondary Outcomes (5)

  • liver enzymes (AST, ALT)

    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-weight ratio)

    12 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Gliclazide + Placebo tea

Dietary Supplement: Placebo group

GP group

ACTIVE COMPARATOR

Gliclazide + Gynostemma pentaphyllum tea

Dietary Supplement: GP group

Interventions

GP groupDIETARY_SUPPLEMENT

Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally

GP group
Placebo groupDIETARY_SUPPLEMENT

Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally

Placebo group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed, drug-naive patients with type 2 diabetes
  • Fasting plasma glucose (FPG)9.0-14.0 mmol/L
  • HbA1C 9-13%

You may not qualify if:

  • Type 1 diabetes
  • Liver failure
  • Kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gerontology, HMU

Hanoi, Vietnam

Location

Related Publications (4)

  • Huyen VT, Phan DV, Thang P, Hoa NK, Ostenson CG. Antidiabetic effect of Gynostemma pentaphyllum tea in randomly assigned type 2 diabetic patients. Horm Metab Res. 2010 May;42(5):353-7. doi: 10.1055/s-0030-1248298. Epub 2010 Mar 8.

    PMID: 20213586BACKGROUND

  • Hoa NK, Phan DV, Thuan ND, Ostenson CG. Screening of the hypoglycemic effect of eight Vietnamese herbal drugs. Methods Find Exp Clin Pharmacol. 2009 Apr;31(3):165-9. doi: 10.1358/mf.2009.31.3.1362514.

    PMID: 19536359BACKGROUND

  • 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: 17283239RESULT

  • Norberg 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: 15220351RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Claes-Goran Ostenson, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

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

December 15, 2008

First Posted

December 16, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

December 6, 2010

Record last verified: 2008-12

Locations

VN(1)