Effect of Extended Release Gymnema Sylvestre Leaf Extract Alone or In Combination With Oral Hypoglycemics or Insulin Regimens for Type 1 and Type 2 Diabetes

Principal Investigator:      Steve Freed, RPh, Diabetes Educator, FAADE

                                                DiabetesInControl.com

                                                800-798-6972

Open Enrollment: current     Ending Enrollment: Jan 15, 2001   Conclusion of Study: April 2001 

Introduction

Gymnema sylvestre is an Indian herb used Ayurveda, the ancient Hindi medicine system of India. Also referred to as Gurmarbooti, gurmar, periploca of the woods in English and meshasringi (meaning “ram’s horn”) in Sanskrit, it is a woody climbing plant that grows in the tropical forests of central and southern India. The leaves are used in herbal medicine preparations, which, when chewed, interfere with the ability to taste sweetness, which explains the Hindi name gurmar—“destroyer of sugar.” Gymnema sylvestre’s primary application was for adult-onset diabetes (NIDDM), a condition for which it continues to be recommended today in India. The leaves were also used for stomach ailments, constipation, water retention, and liver disease.

Ayurvedic treatments employ physician monitored fasting and medication, internal cleansing, and then personalized treatments based upon a well-developed body typing system. Therapies typically include diet, exercise, meditation and herbal supplements.

The gradual hypoglycemic action of Gymnema leaves, first documented in the 1930, differs from the rapid effect of many prescription hypoglycemic drugs.¹ Gymnema leaves raise insulin levels, according to research in healthy volunteers² possible due to regeneration of the b-cells in the pancreas.³ The leaves are also noted for lowering serum cholesterol and triglycerides.⁴ A water-soluble acidic fraction of the leaves provides hypoglycemic actions, possibly gymnemic acid.⁵ Its action in the reduction of intestinal glucose uptake has also been noted.⁶

In the US, Gymnema sylvestre is sold under several brands including Nature’s Way, Natrol, Pro Beta™ and Informulab^® Beta Fast GXR^® . The products promote healthy glucose levels and pancreas function. As a supplement, Gymnema is also used to help diminish sugar intake.

Gymnema sylvestre is generally safe and devoid of side affects although it should be avoided during pregnancy. Administration is recommended under the clinical supervision of a healthcare professional. Gymnema cannot be used in place of insulin to control blood sugar by persons with IDDM or NIDDM.

Trial Design

We intend to treat 100 patients, either Type 1 or Type 2 diabetics.  Males or non-pregnant females with a hemoglobin A₁c>7.3% will be chosen for the study.  An HbA1c will be taken at the beginning and at the conclusion of the study.  Fasting blood glucose and postprandial blood glucose will be measured during the trial. A minimum of 1 fasting blood glucose and 1 postprandial blood glucose will be taken daily for at least 5 of 7 days.  At the end of each 30 day period, the readings will be added and divided by the number of days and reported back as an average fasting and postprandial blood glucose.  Treatment with Beta Fast GXR^® Gymnema sylvestre will be added for a period of three months, 1 x 400mg tablet, twice daily.  At the end of that period, we will obtain another HbA1c.

Efficacy Variables

1. Hemoglobin A₁c

2. Fasting Blood Glucose

3. Postprandial Blood Glucose

Study Procedures

Two 2 weeks prior to start, the patient will monitor for at least 10 fasting and 10- 2hr postprandial readings and bring with to first visit.

Visit 1:  Informed consent will be obtained. A brief history, including questions as to any recent episodes of hypoglycemia will be obtained.  A physical exam obtaining height, weight, pulse and blood pressure will be obtained. A fasting blood glucose and hemoglobin A1c will be obtained.   Concomitant medications will be recorded. A daily fasting and 2 hr postprandial blood glucose for a minimum of 5 each per a week will be required by the patient during the length of the study, these numbers will be reported to the educator monthly, who will get an average fasting and 2hr postprandial reading and fax in at 30, 60 and 90 days.  Patients will continue their current oral hypoglycemic medication (or insulin), diet and exercise regimen and will begin treatment with Beta Fast GXR^® extended release Gymnema Sylvestre tablets. One bottle of Beta Fast GXR^® containing 180 tablets will be dispensed. Patients will be instructed to take two (2) tablets per day, one in AM, one in PM.   The patient is to return in 90 days with bottle of Beta Fast GXR^®. 

Visit 2:  A brief history, including questions as to any episodes of hypoglycemia will be obtained.  A physical exam obtaining height, weight, pulse and blood pressure will be obtained. Any changes in concomitant medications will be recorded.  A fasting blood glucose and HbA₁c will be obtained.  The study medication bottle from visit 1 will be collected.   Tablets remaining will be counted.    

Statistical Analysis

Only patients who complete Visit 2 will be considered in the analysis.   Patients found taking fewer than 153 tablets (15% missed compliance) will be excluded from the analysis. The HbA₁c and the glucose levels from Visit 1 will be compared to those from Visit 2. 

If glucose and HbA₁c levels are lower on Beta Fast GXR^®, we will conclude that this treatment may add incremental benefit in diabetic patients. 

Protocol Deviations:  Limited exceptions to the protocol will be acceptable, provided that there is no marked change in the significant intent of the study.  Thus, slight modifications of numerical entry criteria and timelines are acceptable.

Safety issues:

Side effects are infrequent and there are no reports of severe adverse reactions. Nonetheless, researchers have not yet performed full safety studies; specifically, they have not established the safety of Gymnema for pregnant or nursing women, or for people with severe liver or kidney disease. Also, as for all treatments used to help control blood sugar, the
potential clearly exists for excessive lowering of blood sugar. For this reason, medical supervision is advisable when you use this herb and more frequent blood glucose monitoring is essential.