UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010758 |
|---|---|
| Receipt number | R000012436 |
| Scientific Title | The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison) |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2021/09/15 21:31:13 |
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Basic information
Public title
The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Acronym
DPVD (Diabetes Prevention with Vitamin D) trial
(Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Scientific Title
The effect of activated vitamin D on reducing the progression from impaired glucose tolerance (IGT) to type 2 diabetes (Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Scientific Title:Acronym
DPVD (Diabetes Prevention with Vitamin D) trial
(Phase IV, multicenter, randomized, double blind, placebo controlled, and parallel group comparison)
Region
| Japan |
Condition
Condition
Impaired Glucose Tolerance (IGT)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to evaluate the effect of activated vitamin D to reduce the progression from IGT to type 2 diabetes, as compared with placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
The progression from IGT to type 2 diabetes between the two groups after 3-year treatment.
Key secondary outcomes
1. The improvement ratio from IGT to normoglycemia.
2. The incidence of type 2 diabetes in each subgroup at baseline variables: age (more or less 65 years), sex (male/female), obesity (BMI more or less 25 kg/m2), presence or absence of hypertension (systolic more 140 mmHg and/or diastolic more 90 mmHg), family history of diabetes (yes / no), fasting plasma glucose (more or less 110 mg/dl), 2-hour plasma glucose (more or less 170 mg/dl), 25-hydroxy vitamin D (more or less 20 ng/ml), HOMA-R (-1.6 / 1.61-2.49 / 2.5-), and Insulinogenic Index (more or less 0.4).
3. The incidence of type 2 diabetes after adjusting for treatment group (eldecalcitol or placebo) and each confounding factor variable at baseline: age, sex (male/female), presence or absence of hypertension (systolic more 140 mmHg and/or diastolic more 90 mmHg), body mass index, family history of diabetes (yes / no), HbA1c, fasting plasma glucose, 2-hour plasma glucose, 25-hydroxy vitamin D, HOMA-R, or insulinogenic index.
4. The incidence of adverse events between the two groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Participants receive 0.75 ug of eldecalcitol cap. per day for at least 144 weeks or by the timepoint of progression type 2 diabetes. After one year of enrollment of all 1250 participants, the first interim analysis will be done.In addition, when total 142 participants are diagnosed as type 2 diabetes, that is 60% of the expected diabetes incidence, the second interim analysis will be done.
Interventions/Control_2
Participants receive placebo cap. per day for at least 144 weeks or by the timepoint of progression type 2 diabetes. After one year of enrollment of all 1250 participants, the first interim analysis will be done.In addition, when total 142 participants are diagnosed as type 2 diabetes, that is 60% of the expected diabetes incidence, the second interim analysis will be done.
Interventions/Control_3
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. fasting plasma/serum glucose level <126mg/dl and 2-hour plasma/serum glucose level: 140 to 199mg/dl in a 75g oral glucose tolerance test.
2. HbA1c < 6.5%
Key exclusion criteria
Participants are ineligible if they meet any of the following criteria: have a history of diabetes; participate in other investigational trials; have a history of taking anti-diabetic drugs, other activated vitamin D, or bisphosphonates within past three months; are pregnant; have coronary, peripheral, or cerebrovascular disease; or have some types of a severe disease (e.g., renal insufficiency, hepatic insufficiency, terminal disease).
Target sample size
1250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health
Division name
The First Department of Internal medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyusyushi, Fukuoka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawahara |
Organization
Kokura Medical Association Health Testing and Services Center
Division name
Internal Medicine
Zip code
Address
1-19-17 Nakashima, Kokurakitaku, Kitakyushu, Fukuoka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kokura Medical Association Health Testing and Services Center
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
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
| 2013 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012436
