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The Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases

NCT00300976 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2542

Last updated 2017-08-03

No results posted yet for this study

Summary

(Intervention study) 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.

(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients.

Conditions

Interventions

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 hypoglycemic drugs, ACEI/ARB and statins, respectively. Management goals are: HbA1c \< 6.2%, BP \< 120/75 mmHg, HDL-C 40 mg/dL , LDL-C \< 80 mg/dL, TG \< 120 mg/dL. Follow-up study (Not provided)

BEHAVIORAL

Lifestyle consultation: weight control, diet, exercise

Behavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines. Follow-up study (Not provided)

Sponsors & Collaborators

  • Japan Diabetes Foundation

    collaborator UNKNOWN

  • Japan Foundation for the Promotion of International Medical Research Cooperation

    lead OTHER

Principal Investigators

  • Takashi Kadowaki · Tokyo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2016-03-31
Completion
2021-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300976 on ClinicalTrials.gov