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Type 2 DiabetesPhase 1/2NCT01254084

Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

A Phase 1/2 study testing Gynostemma Pentaphyllum tea in people with Type 2 Diabetes, run by Hanoi Medical University at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Gynostemma Pentaphyllum tea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
2 sitesVietnam
Study dates
Feb 2010to Nov 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, drug-naive patients with type 2 diabetes
  • Fasting plasma glucose: 7-11 mmol/l
  • HbA1C: 7-9%.

Who cannot join

  • Type 1 diabetes
  • Liver and kidney failure

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • National Institute of Gerontology, HMU

    Hanoi

  • National Institute of Gerontology

    Hanoi

Other trials in Vietnam

About this study

Official title: Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

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.

Read the detailed description

In Vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some other Asian countries and was widely used in Southeast Asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. We have previously published the evidences that GP tea possessed anti-diabetic effect with good safety data in newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Conditions
Type 2 Diabetes
Being tested
Gynostemma Pentaphyllum tea, Placebo tea
Keywords
Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gynostemma Pentaphyllum teaDietary supplement

    Also called Gynostemma Pentaphyllum extract

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

  • Placebo teaDietary supplement

    Also called Placebo extract

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

Study groups in NCT01254084
Study groupRoleWhat they receive
Placebo teaPlacebo comparatorDietary Supplement: Placebo tea 3 gram twice daily, orally
Receives: Dietary Supplement: Placebo tea
Gynostemma pentaphyllum TeaActive comparatorGynostemma Pentaphyllum tea 3 grams twice daily, orally
Receives: Dietary Supplement: Gynostemma Pentaphyllum tea

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 10 weeks

Secondary outcomes (5)

  1. Liver enzymes (ALT, AST)

    Measured: 10 weeks

  2. Kidney function (S-creatinine, S-BUN)

    Measured: 10 weeks

  3. Plasma lipids (TG, Cholesterol, HDL-, LDL-)

    Measured: 10 weeks

  4. Blood pressure

    Measured: 10 weeks

  5. Body weight (BMI, hip-waist ratio)

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionSep 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254084
Sponsor's protocol ID
Diabetes II-Study3
Other IDs
Study 3
Status last verified
Feb 2010
First submitted
3 Dec 2010
Last updated
6 Dec 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20213586

  • 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.

    PubMed 17283239

  • 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.

    PubMed 19536359

  • 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.

    PubMed 15220351

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gynostemma Pentaphyllum tea in people with Type 2 Diabetes, run by Hanoi Medical University at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254084, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.

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