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Impact of Mulberry Leaf on Type 2 Diabetes (Mul-DM)
This study is currently recruiting participants.
Verified by University of Mississippi Medical Center, November 2008
Sponsored by: University of Mississippi Medical Center
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00795704
  Purpose

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
Type 2 Diabetes
Drug: Mulberry Leaf Extract
Drug: Placebo
Phase II
Phase III

MedlinePlus related topics: Diabetes
U.S. FDA Resources
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)

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Basic Metabolic Panel, ALT, AST [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: Yes ]

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
Placebo: Placebo Comparator
Control Group
Drug: Placebo
Placebo
Mulberry Leaf Extract: Active Comparator Drug: Mulberry Leaf Extract
Mulberry Leaf Extract 1000 mg three times daily for 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • No diabetes medication adjustments for at least 2 months
  • Stable hemoglobin A1C [Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline]

Exclusion Criteria:

  • On insulin
  • History of overt cardiovascular disease
  • History of missed appointments or non-compliance with medications
  • History of hepatic or renal insufficiency
  • History of hemoglobinopathies
  • Women of reproductive potential not on oral contraceptives
  • Pregnant/nursing women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795704

Contacts
Contact: Daniel M Riche, Pharm.D. 601-984-2640 driche@sopumsmed.edu

Locations
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.            
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississippi Medical Center
  More Information

Publications:
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

Keywords provided by University of Mississippi Medical Center:
Herbal Supplement
Type 2 Diabetes
Mulberry
Hemoglobin A1C

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009