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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00795704
First received: November 19, 2008
Last updated: June 29, 2012
Last verified: June 2012

November 19, 2008
June 29, 2012
April 2008
May 2010   (final data collection date for primary outcome measure)
Hemoglobin A1C [ Time Frame: 3 month minus baseline ] [ Designated as safety issue: No ]
Hemoglobin A1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795704 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels [ Time Frame: Baseline, 1 month, and 3 months ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.
Basic Metabolic Panel, ALT, AST [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Impact of Mulberry Leaf on Type 2 Diabetes
Effect of Mulberry Leaf Extract on Glycemic Durability in Non-insulin Dependent Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Pilot Study (Mul-DM)

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 lookin

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • Drug: Placebo
    Placebo 500 mg #2 capsules by mouth three times daily
  • Placebo Comparator: Placebo
    Control Group
    Intervention: Drug: Placebo
  • Active Comparator: Mulberry Leaf Extract
    Intervention: Drug: Mulberry Leaf Extract

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795704
2008-0053
No
Daniel Riche, University of Mississippi Medical Center
University of Mississippi Medical Center
Not Provided
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississippi Medical Center
University of Mississippi Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP