NCT01254084

Brief Summary

The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

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, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
Last Updated

December 6, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

December 3, 2010

Last Update Submit

December 3, 2010

Conditions

Type 2 Diabetes

Keywords

Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;

Outcome Measures

Primary Outcomes (1)

  • Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test

    All subjects participated in Somatostatin-Insulin-Glucose Infusion Test (SIGIT), lasting 150 minutes, performed at 8am after an 8-10h overnight fast with only tap water allowed ad libitum. Somatostatin was used to suppress endogenous insulin release, thereby allowing estimation of sensitivity to exogenously administered insulin by measuring blood glucose value at 90, 120 and 150 minute of the test (SIGIT mean).

    10 weeks

Secondary Outcomes (5)

  • Liver enzymes (ALT, AST)

    10 weeks

  • Kidney function (S-creatinine, S-BUN)

    10 weeks

  • Plasma lipids (TG, Cholesterol, HDL-, LDL-)

    10 weeks

  • Blood pressure

    10 weeks

  • Body weight (BMI, hip-waist ratio)

    10 weeks

Study Arms (2)

Placebo tea

PLACEBO COMPARATOR

Dietary Supplement: Placebo tea 3 gram twice daily, orally

Dietary Supplement: Placebo tea

Gynostemma pentaphyllum Tea

ACTIVE COMPARATOR

Gynostemma Pentaphyllum tea 3 grams twice daily, orally

Dietary Supplement: Gynostemma Pentaphyllum tea

Interventions

Gynostemma Pentaphyllum teaDIETARY_SUPPLEMENT

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Also known as: Gynostemma Pentaphyllum extract
Gynostemma pentaphyllum Tea
Placebo teaDIETARY_SUPPLEMENT

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Also known as: Placebo extract
Placebo tea

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: 7-11 mmol/l
  • HbA1C: 7-9%.

You may not qualify if:

  • Type 1 diabetes
  • Liver and kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Gerontology, HMU

Hanoi, Vietnam

Location

National Institute of Gerontology

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, 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: 17283239BACKGROUND

  • 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

  • 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: 15220351BACKGROUND

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, Ph.D

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

December 6, 2010

Record last verified: 2010-02

Locations

VN(2)