Type 2 Diabetes
Conditions
Keywords
Herbal Supplement, Type 2 Diabetes, Mulberry, Hemoglobin A1C
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.
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
Interventions
Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months
DRUGPlacebo
Placebo 500 mg #2 capsules by mouth three times daily
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C | 3 month minus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels | 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. |
| Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages | 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. |
Countries
United States
Participant flow
Recruitment details
Recruted from April 2008 - Feb 2010 in University of Mississippi Cardiometabolic clinic.
Pre-assignment details
Two week placebo run-in
Participants by arm
| Arm | Count |
|---|---|
| Placebo Control Group | 12 |
| Mulberry Leaf Extract 500 mg #2 capsules three times daily | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Mulberry Leaf Extract | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 23 Participants |
| Age Continuous | 57.3 years STANDARD_DEVIATION 5.5 | 56 years STANDARD_DEVIATION 7 | 56.7 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 12 | 4 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Primary
Hemoglobin A1C
Time frame: 3 month minus baseline
Population: intention-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hemoglobin A1C | -0.39 percent | Standard Deviation 0.51 |
| Mulberry Leaf Extract | Hemoglobin A1C | -0.26 percent | Standard Deviation 0.5 |
p-value: 0.079t-test, 2 sided
Secondary
Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages
2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.
Time frame: Baseline and 3 months
Population: Intention-to-treat with data submitted baseline and final.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages | -28.1 mg/dL | Standard Deviation 36.3 |
| Mulberry Leaf Extract | Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages | 3.6 mg/dL | Standard Deviation 13.4 |
p-value: <0.05t-test, 2 sided
Secondary
Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels
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.
Time frame: Baseline, 1 month, and 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels | 6 participants |
| Mulberry Leaf Extract | Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels | 4 participants |