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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00499148
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : July 30, 2010
Sponsor:
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: herbal extract; root of woody shrub grown in India/Sri-Lanka Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
Study Start Date : August 2006
Primary Completion Date : August 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bobbie Swearengin, Director, Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00499148     History of Changes
Other Study ID Numbers: BJ82
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: April 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases