Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
|Diabetes Mellitus||Drug: nutritional herbal extract from Salacia oblonga||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306072
|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|