Trial Outcomes & Findings for Impact of Mulberry Leaf on Type 2 Diabetes (NCT NCT00795704)

NCT ID: NCT00795704

Last Updated: 2012-08-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: 3 month minus baseline
• Results posted on: 2012-08-09

Participant Flow

Recruted from April 2008 - Feb 2010 in University of Mississippi Cardiometabolic clinic.

Two week placebo run-in

Participant milestones

Measure	Placebo Control Group	Mulberry Leaf Extract 500 mg #2 capsules three times daily
Overall Study STARTED	12	12
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Placebo Control Group	Mulberry Leaf Extract 500 mg #2 capsules three times daily
Overall Study Withdrawal by Subject	3	2
Overall Study Adverse Event	1	1

Baseline Characteristics

Impact of Mulberry Leaf on Type 2 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=12 Participants Control Group	Mulberry Leaf Extract n=12 Participants 500 mg #2 capsules three times daily	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 7 • n=5 Participants	57.3 years STANDARD_DEVIATION 5.5 • n=7 Participants	56.7 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month minus baseline

Population: intention-to-treat

Outcome measures

Measure	Placebo n=12 Participants Control Group	Mulberry Leaf Extract n=12 Participants 500 mg #2 capsules three times daily
Hemoglobin A1C	-0.39 percent Standard Deviation 0.51	-0.26 percent Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=12 Participants Control Group	Mulberry Leaf Extract n=12 Participants 500 mg #2 capsules three times daily
Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels	6 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Intention-to-treat with data submitted baseline and final.

2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.

Outcome measures

Measure	Placebo n=6 Participants Control Group	Mulberry Leaf Extract n=8 Participants 500 mg #2 capsules three times daily
Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages	-28.1 mg/dL Standard Deviation 36.3	3.6 mg/dL Standard Deviation 13.4

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Mulberry Leaf Extract

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=12 participants at risk Control Group	Mulberry Leaf Extract n=12 participants at risk 500 mg #2 capsules three times daily
Blood and lymphatic system disorders Hospitalization	8.3% 1/12 • Number of events 1 • 1 and 3 months	0.00% 0/12 • 1 and 3 months

Other adverse events

Measure	Placebo n=12 participants at risk Control Group	Mulberry Leaf Extract n=12 participants at risk 500 mg #2 capsules three times daily
Gastrointestinal disorders GI Upset	25.0% 3/12 • Number of events 3 • 1 and 3 months	25.0% 3/12 • Number of events 4 • 1 and 3 months
Skin and subcutaneous tissue disorders Allergy	0.00% 0/12 • 1 and 3 months	8.3% 1/12 • Number of events 1 • 1 and 3 months
Infections and infestations Infection	16.7% 2/12 • Number of events 2 • 1 and 3 months	8.3% 1/12 • Number of events 1 • 1 and 3 months
Endocrine disorders Hyperparathyroidism	8.3% 1/12 • Number of events 1 • 1 and 3 months	0.00% 0/12 • 1 and 3 months

Additional Information

Daniel Riche

University of Mississippi Medical Center

Phone: 601-984-2640

Email: driche@umc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place