ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

This study has been completed.

Sponsored by: Abbott Nutrition
Information provided by: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00499148
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Other: herbal extract; root of woody shrub grown in India/Sri-Lanka
Phase II
Phase III

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Official Title:   Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • positive AUC for plasma glucose [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 4 hours ]

Estimated Enrollment:   59
Study Start Date:   August 2006

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499148

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

Sponsors and Collaborators
Abbott Nutrition

Investigators
Study Director:     Jennifer A. Williams, MPH     Abbott Nutrition    
  More Information


Study ID Numbers:   BJ82
First Received:   July 5, 2007
Last Updated:   July 18, 2007
ClinicalTrials.gov Identifier:   NCT00499148
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 06, 2008




Links to all studies - primarily for crawlers