Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases (J-DOIT3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Japan Diabetes Foundation
Information provided by (Responsible Party):
Japan Foundation for the Promotion of International Medical Research Cooperation
ClinicalTrials.gov Identifier:
NCT00300976
First received: March 8, 2006
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM.


Condition Intervention
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Behavioral: Lifestyle consultation: weight control, diet, exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Japan Foundation for the Promotion of International Medical Research Cooperation:

Primary Outcome Measures:
  • The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death [ Time Frame: Every 12 months, at the end of the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of myocardial infarction, stroke or death [ Time Frame: Every 12 months, at the end of the study. ] [ Designated as safety issue: Yes ]
  • Onset or progression of nephropathy [ Time Frame: Every 6 months, at the end of the study. ] [ Designated as safety issue: Yes ]
  • Lower limb vascular events (amputation or revascularization of lower limb)cerebral revascularization) [ Time Frame: Every 12 months, at the end of the study. ] [ Designated as safety issue: Yes ]
  • Onset or progression of retinopathy [ Time Frame: Every 12 months, at the end of the study. ] [ Designated as safety issue: Yes ]

Enrollment: 2542
Study Start Date: May 2006
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive therapy Behavioral: Lifestyle consultation: weight control, diet, exercise

Behavioral: Lifestyle modification including weight control, with the goal of BMI 22.

Drug: Drugs are added in a stepwise manner to control blood glucose, blood pressure and lipid metabolism, using mainly pioglitazone, ACEI/ARB and statins. Management goals are: HbA1c < 6.2%, BP < 120/75 mmHg, HDL-C 40 mg/dL , LDL-C < 80 mg/dL, TG < 120 mg/dL.

Active Comparator: Conventional therapy Behavioral: Lifestyle consultation: weight control, diet, exercise
Behavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines.

Detailed Description:

The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus by a randomized controlled study in patients with type 2 DM. The primary outcome measure is the incidence of myocardial infarction, stroke, or death.

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects were considered eligible if they were 45 years old or older but younger than 70 years old at study entry, had type 2 diabetes and met both "(1) and (2)" or both "(1) and (3)" described below. [Note: Those who met all three "(1), (2) and (3)" were also considered eligible for inclusion.](1) Glycemic control Those with HbA1c 6.9% or greater despite treatment with any of the three regimens given below. Diet and exercise therapy alone, Diet and exercise therapy plus 1 oral anti-diabetic drug, Diet and exercise therapy plus, GI and 1 other oral anti-anti-diabetic drug (2) Blood pressure control Those with the following casual blood pressure (BP) level as measured on an outpatient basis, Systolic BP 140 mmHg or diastolic BP 90 mmHg while not on an antihypertensive agent, Systolic BP 130 mmHg or diastolic BP 80 mmHg while on 1 or 2 ARB, ACEI or long-acting CCB Those receiving antihypertensive agents other than ARB, ACEI or long-acting CCB were not eligible for study entry, with the exception of those who were receiving these agents for other purposes than blood pressure lowering. (3) Lipid metabolism Those with the following fasting lipid levels while not on a lipid-lowering agent LDL-cholesterol, 120 mg/dL (as calculated by using the Friedewald formula) Triglycerides, 150 mg/dL HDL-cholesterol, < 40 mg/dL Subjects receiving 1 lipid-lowering agent were judged eligible for study entry if they met any of the above criteria. However, care needs to be taken to ensure that those on fibrates discontinue the fibrate treatment at the start of the study when they are assigned to the intensive therapy arm.

Exclusion Criteria: 1. Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg) 2. Those on insulin therapy 3. Those with non-diabetic renal disease 4. Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected 5. Those who tested anti-GAD antibody*-positive 6. Those with LDL-cholesterol 200 mg/dL 7. Those suspected of having secondary hypertension other than renal parenchymal hypertension 8. Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder 9. Those who were receiving antihypertensive agents other than ARB, ACEI, long-acting CCB, except where they were receiving these agents for other purposes than blood pressure lowering 10. Those who were receiving 3 or more antihypertensive agents (i.e., ARB, ACEI, and long-acting CCB), except where they were receiving these agents for other purposes than blood pressure lowering 11. Those with more serious retinopathy than proliferative retinopathy 12. Renal failure (serum Cr: 2.0 mg/dL in men; 1.5 mg/dL in women) 13. Those with a history of cardiac failure or those with cardiac failure 14. Those who were pregnant or potentially pregnant 15. Those who met any of the following criteria and who had BNP 100 pg/mL, Myocardial infarction, Angina pectoris (or a history of disease), History of coronary artery bypass graft (CABG), History of percutaneous coronary angioplasty (PTCA), Other cardiac disease, ECG findings of left ventricular hyperplasia, Abnormal ECG findings (excluding isolated extrasystole or right bundle branch block [RBBB]) 16. Those judged by the physician in charge to be ineligible for study entry

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300976

Locations
Japan
The University of Tokyo
Tokyo, Japan, 113-8655
Sponsors and Collaborators
Japan Foundation for the Promotion of International Medical Research Cooperation
Japan Diabetes Foundation
Investigators
Principal Investigator: Takashi Kadowaki The University of Tokyo
  More Information

No publications provided

Responsible Party: Japan Foundation for the Promotion of International Medical Research Cooperation
ClinicalTrials.gov Identifier: NCT00300976     History of Changes
Other Study ID Numbers: J-DOIT3
Study First Received: March 8, 2006
Last Updated: October 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Foundation for the Promotion of International Medical Research Cooperation:
Blood glucose
Blood pressure
Lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014