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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Information provided by:
Hanoi Medical University
ClinicalTrials.gov Identifier:
NCT01254084
First received: December 3, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Dietary Supplement: Gynostemma Pentaphyllum tea
Dietary Supplement: Placebo tea
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Hanoi Medical University:

Primary Outcome Measures:
  • Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Liver enzymes (ALT, AST) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Kidney function (S-creatinine, S-BUN) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Plasma lipids (TG, Cholesterol, HDL-, LDL-) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Body weight (BMI, hip-waist ratio) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo tea
Dietary Supplement: Placebo tea 3 gram twice daily, orally
Dietary Supplement: Placebo tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Other Name: Placebo extract
Active Comparator: Gynostemma pentaphyllum Tea
Gynostemma Pentaphyllum tea 3 grams twice daily, orally
Dietary Supplement: Gynostemma Pentaphyllum tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Other Name: Gynostemma Pentaphyllum extract

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254084

Locations
Vietnam
National Institute of Gerontology
Hanoi, Vietnam
National Institute of Gerontology, HMU
Hanoi, Vietnam
Sponsors and Collaborators
Hanoi Medical University
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Investigators
Study Director: Claes-Goran Ostenson, MD, Ph.D Karolinska Institutet
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01254084     History of Changes
Other Study ID Numbers: Diabetes II-Study3, Study 3
Study First Received: December 3, 2010
Last Updated: December 3, 2010
Health Authority: Vietnam: Hanoi Medical University review board (HMURB) in Bio-Medical research

Keywords provided by Hanoi Medical University:
Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014