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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964703
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Sin Gon Kim, Korea University Anam Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance) Drug: Rubus occidentalis extract Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Placebo Comparator: control
Active Comparator: Rubus occidentalis extract 900mg
taking Rubus occidentalis extract 900mg/day for 12weeks
Drug: Rubus occidentalis extract
Active Comparator: Rubus occidentalis extract 1800mg
taking Rubus occidentalis extract 1800mg/day for 12weeks
Drug: Rubus occidentalis extract



Primary Outcome Measures :
  1. serum glucose (fasting and post 75g oral glucose tolerance test) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. serum insulin [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sin Gon Kim, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01964703    
Other Study ID Numbers: ED13024
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia