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Completed

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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Key information

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

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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

herbal extract; root of woody shrub grown in India/Sri-Lanka

Other

Primary outcomes

  1. positive AUC for plasma glucose

    Time frame: 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.

    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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