Impact of Mulberry Leaf on Type 2 Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Mulberry Leaf Extract

Registration Number: NCT00795704

Lead Sponsor: University of Mississippi Medical Center

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Control Group
Mulberry Leaf Extract	Mulberry Leaf Extract	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	3 month minus baseline

Secondary Outcome Measures

Name	Time	Method
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.