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

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00499148
First received: July 5, 2007
Last updated: July 29, 2010
Last verified: April 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • positive AUC for plasma glucose [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Bobbie Swearengin, Director, Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00499148     History of Changes
Other Study ID Numbers: BJ82
Study First Received: July 5, 2007
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 25, 2014