Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

Phase 4CompletedNCT01964703

Korea University Anam Hospital29 enrolled

Overview

The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Interventions

Rubus occidentalis extractDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 19 years of age or older * prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl) Exclusion Criteria: * pregnant women * taking anti-hyperglycemic agents within 3 months at the time of enrollment * history of heart failure, myocardial infarction, cerebral infarction * uncontrolled hypertension (systolic BP \> 160mmHg, or diastolic BP \> 100mmHg) * serum triglyceride level \> 500mg/dl * kidney dysfunction (serum Creatinine \> 30% of upper normal limits) * hepatic dysfunction (AST, ALT \> 3 times of upper normal limits) * taking systemic glucocorticoids within 1 month

Outcomes

Primary Outcomes

serum glucose (fasting and post 75g oral glucose tolerance test)

Time frame: 12 weeks

Secondary Outcomes

serum insulin

Time frame: 12 weeks

Data from ClinicalTrials.gov

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