Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00499148
• Lead Sponsor: Abbott Nutrition

Brief Summary

The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Primary Completion: 2007-08
• Study Completion: 2007-10
• Status Verified: 2009-04
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• type 2 diabetes
• Between 18 and 75 years of age
• Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
• If of childbearing potential, is practicing birth control
• BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
• If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit

Exclusion Criteria

• Uses insulin for glucose control or has type 1 diabetes
• History of diabetic ketoacidosis.
• Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
• Active malignancy
• Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
• End state organ failure or status post organ transplant
• History of renal disease
• Current hepatic disease
• History of severe gastroparesis
• Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
• Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
• Clotting or bleeding disorders
• Allergic or intolerant to any ingredient found in the study products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
positive AUC for plasma glucose	4 hours

Secondary Outcome Measures

Name	Time	Method
positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.	4 hours

Trial Locations

Locations (1)

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States