UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000911 |
|---|---|
| Receipt number | R000001101 |
| Scientific Title | The randomized trial about the efficacy of a 2-Day in-Hospital Diabetes Educational Program for prevention of type 2 diabetes (The JOETSU Diabetes Prevention Trial) |
| Date of disclosure of the study information | 2007/11/29 |
| Last modified on | 2007/11/29 14:27:34 |
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Basic information
Public title
The randomized trial about the efficacy of a 2-Day in-Hospital Diabetes Educational Program for prevention of type 2 diabetes
(The JOETSU Diabetes Prevention Trial)
Acronym
The 2-Day in-Hospital Diabetes Educational Program for patients of Impared Glucose Tolerance (The JOETSU Diabetes Prevention Trial)
Scientific Title
The randomized trial about the efficacy of a 2-Day in-Hospital Diabetes Educational Program for prevention of type 2 diabetes
(The JOETSU Diabetes Prevention Trial)
Scientific Title:Acronym
The 2-Day in-Hospital Diabetes Educational Program for patients of Impared Glucose Tolerance (The JOETSU Diabetes Prevention Trial)
Region
| Japan |
Condition
Condition
Impared Glucose Tolerance
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed the effects of a 2-day in-hospital diabetes educational program in preventing or delaying progression of impaired glucose tolerance (IGT) to type 2 diabetes, including analysis of changes in serum lipids, body weight, and blood pressure following the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All participants were seen at 3-month intervals by their physicians. Blood and urine samples were taken for examination.
We estimated the incidence of type 2 diabetes.
Key secondary outcomes
All participants were seen at 3-month intervals by their physicians. Body weight, waist circumference, and blood pressure were measured. We estimated the efficay of our program for changes in serum lipids, body weight, and blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the STH (Short Term Hospitalization) group, participants took a 9-lesson curriculum, designed as a clinical course, covering special diet, exercise, and behavior modification to help them change their behavior. Each curriculum, instructed by case managers, dietitians, pharmacists, physical therapists, nurses, and physicians on a one-to-one or group basis, was flexible, culturally sensitive, and individualized. We set the diet at 25-30 kcal/kg of ideal body weight in each case, and the goal of dietary intervention was a total daily intake of fat that was less than 20-25 percent of daily energy intake. In addition, participants received exercise therapy in the form of participation in a traditional Japanese physical exercise radiobroadcast program. We instructed the participants to continue walking or doing the radiobroadcast physical exercise for at least 30 minutes per day, more than 5 times a week after discharge from hospital. Subsequent individual sessions every 3 months with the case managers or dietitians, designed to reinforce the behavioral changes, were similar to the program received by members of the DES group.
Interventions/Control_2
In the DES (Diabetes Education and Support) group, participants were provided with written information and periodical 20 to 30 min individual sessions that emphasized the importance of a healthy lifestyle. Participants were encouraged to follow the diabetes guidebook (Diabetes Treatment Guidebook 2003) issued by the Japan Diabetes Society. They were also instructed to follow the equivalent of the food guidebook (Food Nutrition Database for Diabetes Diet Therapy, version 6, 2002, Japan Diabetes Society) to reduce their weight, and to increase their physical activity.
Interventions/Control_3
In the CONT (Control) group, participants were given general information about diabetes and impaired glucose tolerance. Their physician also provided diabetes information brochures with general instructions for diet and improvement of lifestyle, but no individual instruction or formal group counseling sessions were conducted.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We screened for patients aged between 20 and 70 years, BMI: 20–34 kg/m2, fasting plasma glucose concentration ≥100 mg/dl (5.6 mmol/l), or HbA1c level between 5.2 and 6.4%. The patients were eligible for our study if they had impaired glucose tolerance – defined as plasma glucose concentration ≤ 125 mg/dl (6.9 mmol/l) in the fasting state, and 140 to 199 mg/dl (7.8 to 11.0 mmol/l) two hours after a 75 g oral glucose load, according to the 2003 ADA criteria. In addition, all participants were confirmed to have systolic blood pressure <150mmHg, diastolic blood pressure <100mmHg, total cholesterol <300mg/dl, triglycerides <220mg/dl, and LDL-cholesterol <180mg/dl.
Key exclusion criteria
We exclude patients who were diabetes, hypertension, or hyperlipidemia with taking any medication which might affect glycemic control.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawahara |
Organization
Niigata-Rousai Hospital, Joetsu, Japan
Division name
Department of Internal Medicine
Zip code
Address
1-7-12, Touun-cho, Joetsu-shi, Niigata 942-8502, Japan
TEL
025-543-3123
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawahara |
Organization
Niigata-Rousai Hospital, Joetsu, Japan
Division name
Department of Internal Medicine
Zip code
Address
1-7-12, Touun-cho, Joetsu-shi, Niigata 942-8502, Japan
TEL
025-543-3123
Homepage URL
http://www.niigatah.rofuku.go.jp/
k-tetsuy@niirou.jp
Sponsor or person
Institute
Niigata-Rousai Hospital, Joetsu, Japan
Institute
Department
Personal name
Funding Source
Organization
Niigata-Rousai Hospital, Joetsu, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The cumulative incidence of type 2 diabetes was lower in the STH and DES groups than in the CONT group through out the 3-year follow-up period. The crude incidence was 8.0, 10.7, and 13.2 cases per 100 person-years for STH, DES, and CONT groups, respectively. The incidence of diabetes was 42% lower (95% confidence interval, 32-51%) in the STH group and 29% lower (95% confidence interval, 17-40%) in the DES group than in the CONT group. The incidence of diabetes was 22% lower (95% confidence interval, 11-32%) in the STH group than in DES group.
19th World Diabetes Congress - Cape Town 2006
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 29 | Day |
Last modified on
| 2007 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001101
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