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

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

Official title:

Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964703
• Other study ID #: ED13024
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2013
• Last updated: October 14, 2013
• Start date: April 2013

Study information

• Verified date: October 2013
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)
• Prediabetic State

Intervention

Drug:
• Rubus occidentalis extract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers		12 weeks	Yes
Primary	serum glucose (fasting and post 75g oral glucose tolerance test)		12 weeks	Yes
Secondary	serum insulin		12 weeks	Yes