NCT00795704

Impact of Mulberry Leaf on Type 2 Diabetes

Effect of Mulberry Leaf Extract on Glycemic Durability in Non-insulin Dependent Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Pilot Study (Mul-DM)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Mulberry Leaf Extract	Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months
DRUG	Placebo	Placebo 500 mg #2 capsules by mouth three times daily

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-11-21
• Last updated: 2012-08-09
• Results posted: 2012-08-09

Locations

1 site across 1 country: United States