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
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Mulberry Leaf Extract
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruted from April 2008 - Feb 2010 in University of Mississippi Cardiometabolic clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two week placebo run-in

Reporting Groups
  Description
Placebo Control Group
Mulberry Leaf Extract 500 mg #2 capsules three times daily

Participant Flow:   Overall Study
    Placebo     Mulberry Leaf Extract  
STARTED     12     12  
COMPLETED     8     9  
NOT COMPLETED     4     3  
Withdrawal by Subject                 3                 2  
Adverse Event                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Control Group
Mulberry Leaf Extract 500 mg #2 capsules three times daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Mulberry Leaf Extract     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 7     57.3  ± 5.5     56.7  ± 6.2  
Gender  
[units: participants]
     
Female     8     8     16  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



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

2.  Secondary:   Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels   [ Time Frame: Baseline, 1 month, and 3 months ]

3.  Secondary:   Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages   [ Time Frame: Baseline and 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel Riche
Organization: University of Mississippi Medical Center
phone: 601-984-2640
e-mail: driche@umc.edu


Publications:

Responsible Party: Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00795704     History of Changes
Other Study ID Numbers: 2008-0053
Study First Received: November 19, 2008
Results First Received: April 16, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board