Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after ingestion of a high-carbohydrate control meal.
Drug: nutritional herbal extract from Salacia oblonga
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes|
- The primary variable to be measured was positive AUC (0-180 minutes) for plasma glucose.
- The secondary variables to be measured were:
- · Positive AUC (0 to 120 minutes) for plasma and serum glucose and positive AUC (0 to 180 minutes) for serum glucose
- · Adjusted peak value for plasma and serum glucose
- · Adjusted peak value for serum insulin
- · Positive AUC 0-180 (0 to 120) minutes for serum insulin
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||September 2005|
Although we have generated a good quantity of animal and human data on the salacinol extract, we have not explored the effect of the salacinol extract on postprandial glycemia or insulinemia in patients with type 2 diabetes.
We planned to study 66 patients with diabetes in this multicenter, randomized, double-blind, three-treatment, crossover study. While in a fasted state, subjects were to consume one of the following three meals: a standard liquid meal containing 110 g carbohydrate, 18 g protein, 12 g fat, and 620 kilocalories (Control); Control plus 240 mg Salacia oblonga extract; and Control plus 480 mg Salacia oblonga extract. Postprandial serum glucose and serum insulin samples were to be analyzed for 180 min.
|United States, Minnesota|
|Edina, Minnesota, United States, 55435|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45236|
|Study Director:||Jennifer A Williams, MPH||Ross Products Division of Abbott Laboratories|