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
1 other identifier
interventional
59
1 country
2
Brief Summary
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Aug 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJuly 30, 2010
April 1, 2009
1 year
July 5, 2007
July 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
positive AUC for plasma glucose
4 hours
Secondary Outcomes (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.
4 hours
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (2)
Radiant Research
Edina, Minnesota, 55435, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer A. Williams, MPH
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 5, 2007
First Posted
July 11, 2007
Study Start
August 1, 2006
Primary Completion
August 1, 2007
Study Completion
October 1, 2007
Last Updated
July 30, 2010
Record last verified: 2009-04