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OpenTrials
Completed

NCT Number: NCT01964703

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

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).

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Key information

Conditions

Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rubus occidentalis extract

Drug

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. serum insulin

    Time frame: 12 weeks

Other outcomes

  1. HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
First posted
Oct 17, 2013
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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