NCT Number: NCT00499148
Efficacy Study Testing 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.
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Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Radiant Research, Edina, Minnesota, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
positive AUC for plasma glucose
Time frame: 4 hours
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Abbott Nutrition
Industry
Registry information
Official study title
Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jul 11, 2007
- Registry last updated
- Jul 30, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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