Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes

Completed · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after ingestion of a high-carbohydrate control meal.

Key facts

Study ID

NCT00306072

Run by

Ross Products

People needed

82

Starts

2005-06-01

Expected to finish

2005-09-01

Last updated by the study team

2010-01-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has type 2 diabetes mellitus verified by prescription of oral antihyperglycemic medications.
• Subject is 18 to 75 years of age, inclusively.
• Subject is male or a nonpregnant, nonlactating female, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
• Subject has a body mass index (BMI) of 18 - 35 kg/m2.
• Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

You may not qualify if…

• Subject uses exogenous insulin for glucose control.
• Subject states that he/she has an infection (requiring medication or hospitalization).
• Subject states that he/she has current hepatic disease.
• Subject states that he/she has had surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
• Subject has a first-degree relative enrolled in the current study.
• Subject states that he/she has an active malignancy (subjects with cutaneous malignancies, other than melanoma, may be included in the study).
• Subject states that he/she has had a significant cardiovascular event < 12 weeks prior to study entry.
• Subject states that he/she has end stage organ failure, including clinically advanced renal disease as assessed by the study physician.
• Subject states that he/she is status post-organ transplantation.
• Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• Subject states that he/she has active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
• As determined by the study physician, subject is taking daily medications or dietary supplements at doses that would interfere with nutrient absorption, metabolism, excretion or gastric motility.
• Subject states that he/she has an allergy or intolerance to any ingredient found in the study products.

Where it is running

• Radiant Research — Edina, Minnesota, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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