Impact of Mulberry Leaf on Type 2 Diabetes

Study Overview
=================
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

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)

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Mulberry Leaf Extract
* Drug: Placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control Group | Drug: Placebo<br>* Placebo 500 mg #2 capsules by mouth three times daily<br>|
| Active Comparator: Mulberry Leaf Extract<br> | Drug: Mulberry Leaf Extract<br>* Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months<br>* Other names: Morus alba;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C |  | 3 month minus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 month, and 3 months | 
| 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. | Baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herbal Supplement, Type 2 Diabetes, Mulberry, Hemoglobin A1C