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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: herbal extract; root of woody shrub grown in India/Sri-Lanka

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
positive AUC for plasma glucose	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Director: Jennifer A. Williams, MPH, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 5, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 11, 2007

Study Record Updates

• Last Update Posted (Estimate): July 30, 2010
• Last Update Submitted That Met QC Criteria: July 29, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BJ82