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

Type 2 Diabetes Clinical Trial

Official title:

Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499148
• Other study ID #: BJ82
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: July 29, 2010
• Start date: August 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2009
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• herbal extract; root of woody shrub grown in India/Sri-Lanka

Locations

Country	Name	City	State
United States	Radiant Research	Cincinnati	Ohio
United States	Radiant Research	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive AUC for plasma glucose		4 hours	No
Secondary	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	No