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Japan Early Diabetes Intervention Study (JEDIS)

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ClinicalTrials.gov Identifier: NCT00464594
Recruitment Status : Unknown
Verified April 2007 by Japan Early Diabetes Intervention Study Group.
Recruitment status was:  Recruiting
First Posted : April 23, 2007
Last Update Posted : April 24, 2007
Sponsor:
Information provided by:
Japan Early Diabetes Intervention Study Group

Tracking Information
First Submitted Date  ICMJE April 19, 2007
First Posted Date  ICMJE April 23, 2007
Last Update Posted Date April 24, 2007
Study Start Date  ICMJE April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2007)
FPG >= 140mg/dl and HbA1c >= 7.0%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Japan Early Diabetes Intervention Study
Official Title  ICMJE A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
Brief Summary The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).
Detailed Description In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Behavioral: Standard lifestyle guidance
  • Drug: Lifestyle guidance and monotherapy with acarbose
  • Drug: Lifestyle guidance and monotherapy with metformin
  • Drug: Lifestyle guidance and monotherapy with gliclazide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: April 19, 2007)
2560
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9%

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Undergoing treatment with steroids
  • Secondary diabetes mellitus
  • Diabetes mellitus due to suspected gene abnormalities
  • BMI >= 35 kg/m2 or BMI < 18.5 kg/m2
  • Undergone a surgery
  • Severe hyperuricemia (gout) associated with organ dysfunction
  • Severe vascular diseases with organ dysfunction
  • Cancer or other malignant neoplasms
  • Liver cirrhosis or chronic hepatic, chronic renal failure
  • Gastrointestinal disorders
  • Always performing rigorous muscular exercise
  • Severe infection or serious trauma
  • Women who are pregnant
  • Alcohol dependence or drug dependence
  • Drug allergy
  • Anemic
  • Abnormal hemoglobinuria
  • Severe mental disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464594
Other Study ID Numbers  ICMJE JEDIS ver.4.0
UMIN000000681
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Japan Early Diabetes Intervention Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Takeshi Kuzuya Jichi Medical University
PRS Account Japan Early Diabetes Intervention Study Group
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP