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Sponsored by: |
University of Mississippi Medical Center |
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Information provided by: | University of Mississippi Medical Center |
ClinicalTrials.gov Identifier: | NCT00795704 |
The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline [before placebo run-in period] and 3 months. Evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. Subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. The subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (Nature-Gen, San Diego, CA) or matching placebo three times daily with meals for 3 months. Patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. To ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. Each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (SMBG), and donated blood for clinical laboratory tests. Standard recommendations for therapeutic lifestyle intervention will be given to both groups. All the clinical laboratory tests will be performed at the University of Mississippi Medical Center. All patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar looking capsules.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Mulberry Leaf Extract Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Mulberry Leaf Extract on Glycemic Durability in Non-Insulin Dependent Diabetes Mellitus: a Double-Blind, Randomized, Placebo-Controlled Pilot Study (Mul-DM) |
Estimated Enrollment: | 24 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Control Group
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Drug: Placebo
Placebo
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Mulberry Leaf Extract: Active Comparator |
Drug: Mulberry Leaf Extract
Mulberry Leaf Extract 1000 mg three times daily for 3 months
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel M Riche, Pharm.D. | 601-984-2640 | driche@sopumsmed.edu |
United States, Mississippi | |
University of Mississippi Medical Center | Recruiting |
Jackson, Mississippi, United States, 39216 | |
Contact: Daniel M Riche, Pharm.D. 601-984-2640 driche@sop.umsmed.edu | |
Contact: Honey E East, M.D. 601-984-5660 heast@umsmed.edu | |
Principal Investigator: Daniel M Riche, Pharm.D. |
Principal Investigator: | Daniel M Riche, Pharm.D. | University of Mississippi Medical Center |
Responsible Party: | The University of Mississippi School of Pharmacy and Medicine ( Daniel M. Riche, Pharm.D., BCPS ) |
Study ID Numbers: | 2008-0053 |
Study First Received: | November 19, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795704 |
Health Authority: | United States: Institutional Review Board |
Herbal Supplement Type 2 Diabetes Mulberry Hemoglobin A1C |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |