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Impact of Mulberry Leaf on Type 2 Diabetes (Mul-DM)

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ClinicalTrials.gov Identifier: NCT00795704
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : August 9, 2012
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Mulberry Leaf Extract Drug: Placebo Phase 2 Phase 3

Detailed Description:
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 lookin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : April 2008
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Control Group
Drug: Placebo
Placebo 500 mg #2 capsules by mouth three times daily
Active Comparator: Mulberry Leaf Extract Drug: Mulberry Leaf Extract
Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months
Other Names:
  • Mulberry
  • Morus indica L.
  • Morus alba


Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: 3 month minus baseline ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels [ Time Frame: Baseline, 1 month, and 3 months ]
    Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.

  2. Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages [ Time Frame: Baseline and 3 months ]
    2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795704


Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
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: Daniel Riche, Assistant Professor of Pharmacy Practice and Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00795704     History of Changes
Other Study ID Numbers: 2008-0053
First Posted: November 21, 2008    Key Record Dates
Results First Posted: August 9, 2012
Last Update Posted: August 9, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases