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NCT Number: NCT01254084

Effect of Gynostemma Pentaphyllum Tea in 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Institute of Gerontology, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Type 1 diabetes
  • Liver and kidney failure

Treatment and study plan

Gynostemma Pentaphyllum tea

Dietary Supplement

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

Other names: Gynostemma Pentaphyllum extract

Placebo tea

Dietary Supplement

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

Other names: Placebo extract

Primary outcomes

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

    Time frame: 10 weeks

    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).

Secondary outcomes

  1. Liver enzymes (ALT, AST)

    Time frame: 10 weeks

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

    Time frame: 10 weeks

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

    Time frame: 10 weeks

  4. Blood pressure

    Time frame: 10 weeks

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

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

  • Karolinska Institutet
  • Swedish International Development Cooperation Agency (SIDA)

Registry information

Official study title

Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 6, 2010
Registry last updated
Dec 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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