Status:
COMPLETED
Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
Lead Sponsor:
Ross Products
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 hig...
Detailed Description
Although we have generated a good quantity of animal and human data on the salacinol extract, we have not explored the effect of the salacinol extract on postprandial glycemia or insulinemia in patien...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00306072
Start Date
June 1 2005
End Date
September 1 2005
Last Update
January 27 2010
Active Locations (2)
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1
Radiant Research
Edina, Minnesota, United States, 55435
2
Radiant Research
Cincinnati, Ohio, United States, 45236